Pediatric Cancer Clinical Trials Intelligence
Monthly Update Report for Trials Started in August 2026
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1: Summary data from new trials identified for Pediatric Cancer.
Overview
Number of Trials: 26
The 26 trials span pediatric and adult oncology, covering targeted therapies, immunotherapy, CAR T-cell therapy, radiotherapy techniques, supportive care, and behavioral/digital interventions. Cancer types include NSCLC, SCLC, hematologic malignancies, brain tumors, sarcomas, and gynecologic cancers. Many trials focus on novel biomarker-driven agents, CAR T-cell products, and quality-of-life interventions for survivors.
Common Criteria Across Trials
Common Inclusion
- Age-specific eligibility (pediatric, AYA, or adult ranges)
- Histologically or radiographically confirmed diagnosis
- Adequate organ/marrow/renal/hepatic function
- Measurable or evaluable disease per RECIST/RANO criteria
- Acceptable performance status (ECOG/Karnofsky/Lansky)
- Willingness to provide informed consent/assent
- Adequate contraception use for reproductive-age participants
Common Exclusion
- Active uncontrolled infections
- Prior treatment with similar investigational agents
- Significant cardiac, hepatic, or renal dysfunction
- Active autoimmune disease requiring systemic treatment
- Pregnancy or breastfeeding
- Known HIV/HBV/HCV infection unless controlled
- Concurrent malignancy requiring treatment
Outcomes Summary
Primary Outcomes
- Safety and tolerability (adverse events, dose-limiting toxicities) (14 trials)
- Efficacy/response rate (ORR, PFS, OS) (10 trials)
- Feasibility/acceptability of intervention (6 trials)
- Maximum tolerated dose (MTD) (4 trials)
- Quality of life / patient-reported outcomes (5 trials)
Secondary Outcomes
- Pharmacokinetics (5 trials)
- Overall survival (6 trials)
- Patient adherence/engagement (4 trials)
- Biomarker correlation with response (4 trials)
- Toxicity/late effects monitoring (5 trials)
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT07784959 — Requires ALK-positive NSCLC; excludes other actionable driver mutations
- NCT07549022 — Requires homozygous MTAP deletion confirmed by NGS
- NCT07358260 — Requires B7-H3 expression by IHC (H score >100)
- NCT07521657 — Requires NF1 pathogenic alteration or germline NF1 diagnosis; excludes IDH/H3/BRAF mutations
- NCT07346157 — Cohort 2 requires cf-DNA positivity in CSF via CLIA-certified testing
Unique or Unusual Criteria
- NCT07278739 — Uses machine learning algorithm to identify high mortality-risk patients for enrollment
- NCT07022678 — Requires minimum one visible/erupted tooth; excludes Down syndrome-associated AML
- NCT07436611 — Requires prior response to pulsed dye laser therapy with purpura/blanching
- NCT07573111 — Excludes patients with implanted devices prone to bacterial seeding due to Listeria-based product
- NCT07681791 — Requires parent-teen dyad participation with daily Facebook use requirement
Trials with Emerging Treatments
- NCT07784959 — NXP900 + Lorlatinib in ALK-positive NSCLC
Items: NXP900
Note: Novel SRC/YES1 kinase inhibitor combined with approved ALK inhibitor; no FDA approval yet. - NCT07625644 — BL-M14D1 and Atezolizumab in SCLC
Items: BL-M14D1
Note: Novel DLL3-targeted antibody-drug conjugate combined with checkpoint inhibitor. - NCT07689175 — Adaptive Dosing of Immune Checkpoint Inhibitors in HCC
Items: Ipilimumab (adaptive dosing)
Note: Novel adaptive dosing strategy for existing checkpoint inhibitors in Child-Pugh B HCC. - NCT07551583 — Nivolumab Plus AVD in Pediatric Hodgkin Lymphoma
Items: Nivolumab + AVD regimen
Note: Novel combination of immunotherapy with standard chemo in pediatric early-stage HL. - NCT07358260 — B7-H3.CD28Z.CART Cells in Pediatric Solid Tumors
Items: B7-H3.CD28Z.CART cells
Note: Investigational CAR T-cell therapy, no FDA approval, targeting B7-H3 in solid tumors. - NCT07680439 — BCB-276 CAR T Cell Therapy for DIPG
Items: BCB-276
Note: Novel locoregional CAR T-cell therapy for pediatric brainstem glioma; FDA breakthrough designation. - NCT07549022 — BMS-986504 in MTAP-deleted MPNST
Items: BMS-986504
Note: Novel PRMT5 inhibitor selectively targeting MTAP-deleted tumors; not yet FDA approved. - NCT07573111 — QUAIL-100 in Post-HSCT Leukemia/MDS
Items: QUAIL-100
Note: First-in-human Listeria-based investigational biologic; mechanism undisclosed. - NCT07061626 — Rhenium-186 NanoLiposome via CED in Pediatric Brain Tumors
Items: Rhenium-186 Obisbemeda (186RNL)
Note: Novel radiotherapeutic nanoliposome delivered via convection-enhanced delivery; investigational. - NCT07436611 — Rapamycin Cream for Port Wine Stains
Items: Rapamycin cream
Note: Novel topical mTOR inhibitor formulation for pediatric vascular malformation, not FDA-approved for this use. - NCT07374315 — WashU Extended Learning Canvas for Leukemia Survivors
Items: Modified Guided Self-Help Family Intervention
Note: Novel family-based behavioral intervention, not a drug/biologic.
3: Individual Trial Overviews
NCT07784959
A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer Genomic-based
Organization/Sponsor: Nuvectis Pharma, Inc.
Example patient: A 55-year-old adult with metastatic ALK-positive NSCLC previously treated with lorlatinib and one line of chemotherapy, without known resistance mutations or other targetable driver alterations.
Phase 1b
NCT07784959
A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer Genomic-based
Organization/Sponsor: Nuvectis Pharma, Inc.
Example patient: A 55-year-old adult with metastatic ALK-positive NSCLC previously treated with lorlatinib and one line of chemotherapy, without known resistance mutations or other targetable driver alterations.
Phase 1b
Interventions
-
Drug: Lorlatinib
Summary: Third-generation ATP-competitive ALK/ROS1 tyrosine kinase inhibitor that blocks ALK-driven signaling, inhibiting tumor growth in ALK-positive NSCLC; crosses blood-brain barrier. Source: FDA label, NCI Thesaurus. -
Drug: NXP900
Summary: Oral SRC family kinase (SRC/YES1) inhibitor that locks kinases in inactive conformation, blocking oncogenic signaling and tumor proliferation; combined with lorlatinib to overcome resistance. Source: NCI Thesaurus, Web Search summary.
Key Inclusion
- 18 years or older
- Unresectable, metastatic or locally advanced ALK-positive NSCLC
- Received lorlatinib as first or second line TKI
- One prior line of systemic chemotherapy permitted
- Tolerated lorlatinib dose being studied or higher
Key Exclusion
- Known ALK mutations causing lorlatinib resistance
- Other actionable oncogenic drivers with approved targeted therapies (e.g., MET, EGFR, HER2)
- Contraindications to lorlatinib per USPI
NCT07625644
A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer
Organization/Sponsor: SystImmune Inc.
Example patient: A 62-year-old man with newly diagnosed extensive-stage small cell lung cancer, ECOG PS 1, measurable disease, normal organ function, and no autoimmune disease or prior ADC therapy, eligible for platinum-based chemoimmunotherapy.
Phase 3
NCT07625644
A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer
Organization/Sponsor: SystImmune Inc.
Example patient: A 62-year-old man with newly diagnosed extensive-stage small cell lung cancer, ECOG PS 1, measurable disease, normal organ function, and no autoimmune disease or prior ADC therapy, eligible for platinum-based chemoimmunotherapy.
Phase 3
Interventions
-
Biologic/ADC + Immunotherapy: BL-M14D1 and Atezolizumab
Summary: BL-M14D1 is a DLL3-targeted antibody-drug conjugate combined with atezolizumab, a PD-L1 blocking monoclonal antibody that enhances T-cell mediated anti-tumor immunity. Used for extensive-stage SCLC. Source: FDA label, NCI Thesaurus, Web Search. -
Chemotherapy + Immunotherapy: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Summary: Standard-of-care regimen combining carboplatin/etoposide chemotherapy with atezolizumab (PD-L1 inhibitor), followed by maintenance atezolizumab plus lurbinectedin, a DNA-damaging agent, for extensive-stage SCLC. Source: FDA label, NCI Thesaurus, Web Search.
Key Inclusion
- Histologically confirmed first-line extensive-stage SCLC
- Eligible for platinum-based chemo plus anti-PD-L1 inhibitor
- At least one measurable lesion (RECIST v1.1)
- ECOG performance status 0-1
- Adequate organ function
Key Exclusion
- Platinum/etoposide treatment for limited-stage SCLC within 6 months
- Prior topoisomerase inhibitor-based ADC therapy
- History of severe heart disease
- Active autoimmune or inflammatory disease
- Other prior/concurrent malignancies unless disease-free 3+ years
NCT07278739
A Randomized Controlled Trial of an Intervention Called "Algorithm-Enabled Patients Activated in Cancer Care Through Teams" (A-PACT) to Improve Goals of Care Communication for People With Cancer
Organization/Sponsor: SWOG Cancer Research Network
Example patient: A 62-year-old woman with metastatic solid tumor, deemed high risk by ML mortality algorithm, currently receiving chemotherapy, not enrolled in hospice, willing to complete PRO surveys by phone.
Phase N/A
NCT07278739
A Randomized Controlled Trial of an Intervention Called "Algorithm-Enabled Patients Activated in Cancer Care Through Teams" (A-PACT) to Improve Goals of Care Communication for People With Cancer
Organization/Sponsor: SWOG Cancer Research Network
Example patient: A 62-year-old woman with metastatic solid tumor, deemed high risk by ML mortality algorithm, currently receiving chemotherapy, not enrolled in hospice, willing to complete PRO surveys by phone.
Phase N/A
Interventions
-
Behavioral: Telephone-Based Intervention
Summary: Uses regular phone-based support and reminders from lay health workers to improve goals-of-care communication and treatment adherence in high-risk cancer patients. Source: NCI Thesaurus, Web Search. -
Observational Tool: Questionnaire Administration
Summary: Collects patient-reported outcomes assessing quality of life, psychological, and physical impacts without direct biological mechanism. Source: NCI Thesaurus, Web Search. -
Observational Tool: Interview
Summary: Qualitative method gathering patient experiences and preferences regarding cancer care and communication. Source: NCI Thesaurus, Web Search. -
Data Collection: Electronic Health Record Review
Summary: Analyzes existing patient data to assess outcomes and support personalized feedback in cancer care. Source: NCI Thesaurus, Web Search. -
Educational: Educational Intervention
Summary: Provides educational activities such as lectures, brochures, and multimedia to improve knowledge and beliefs and support goals-of-care discussions. Source: NCI Thesaurus, Web Search. -
Standard of Care: Best Practice
Summary: Represents usual standard-of-care communication and treatment approach used as comparator to the A-PACT intervention. Source: NCI Thesaurus, Web Search.
Key Inclusion
- Diagnosis of solid tumor malignancy of any stage
- High risk with >=20% 6-month mortality estimate via ML algorithm
- Not receiving or planning hospice care at registration
- Actively receiving or planning systemic anti-cancer therapy within 3 months
- Age >=18 years
- Able to complete PRO questionnaires in English or Spanish
- Must provide valid telephone number for contact
- Informed consent required
Key Exclusion
- Pre-existing plans to enter hospice care
- Unable to provide valid contact telephone number
- Cannot complete baseline PRO forms within 14 days prior to registration
NCT07594431
A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
Organization/Sponsor: Stanford University
Example patient: A 14-year-old with metastatic osteosarcoma presenting a 3 cm lung metastasis, ECOG 1, Lansky score 80, no prior radiation, and negative pregnancy test, eligible for randomization.
Phase 2
NCT07594431
A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
Organization/Sponsor: Stanford University
Example patient: A 14-year-old with metastatic osteosarcoma presenting a 3 cm lung metastasis, ECOG 1, Lansky score 80, no prior radiation, and negative pregnancy test, eligible for randomization.
Phase 2
Interventions
-
Radiotherapy: Standard radiotherapy
Summary: Fractionated high-energy radiation delivered per standard practice to damage tumor DNA and prevent cell growth; used palliatively for metastatic disease. Source: NCI Thesaurus, Summary of Web Search. -
Radiotherapy: LATTICE Radiotherapy
Summary: Delivers a grid-like pattern of high-dose radiation spots within bulky tumors to spare surrounding tissue while enhancing tumor control, under investigation in pediatric and adult oncology. Source: Summary of Web Search.
Key Inclusion
- Metastatic cancer confirmed histologically, cytologically, or radiographically
- One to two non-brain metastases >2.5 cm in short axis
- Age ≥12 years
- ECOG performance status 0-2
- Lansky Play-Performance score 50-100 for ages 12-16
- Negative pregnancy test if childbearing potential
- Signed informed consent/assent
Key Exclusion
- Prior radiation therapy to the tumor to be treated
- Active pregnancy
- High risk of radiation complications (lupus, scleroderma, Li Fraumeni syndrome)
- Tumor is a hematologic malignancy (lymphoma or myeloma)
NCT07689175
Phase 2 Trial of Adaptive Dosing of Immune Checkpoint Inhibitors for Unresectable Child Pugh B Hepatocellular Carcinoma
Organization/Sponsor: University of Texas Southwestern Medical Center
Example patient: A 62-year-old man with cirrhosis-related, biopsy-confirmed unresectable HCC, Child-Pugh B7, ECOG 1, no prior immunotherapy, and adequate organ function meets eligibility for adaptive checkpoint inhibitor dosing.
Phase 2
NCT07689175
Phase 2 Trial of Adaptive Dosing of Immune Checkpoint Inhibitors for Unresectable Child Pugh B Hepatocellular Carcinoma
Organization/Sponsor: University of Texas Southwestern Medical Center
Example patient: A 62-year-old man with cirrhosis-related, biopsy-confirmed unresectable HCC, Child-Pugh B7, ECOG 1, no prior immunotherapy, and adequate organ function meets eligibility for adaptive checkpoint inhibitor dosing.
Phase 2
Interventions
-
Biologic/Immunotherapy: Ipilimumab (3 mg/kg)
Summary: Anti-CTLA-4 monoclonal antibody that blocks inhibitory T-cell signaling to enhance anti-tumor immune response; used in combination checkpoint inhibition for advanced HCC. Source: Summary of Web Search. -
Biologic/Immunotherapy: Nivolumab
Summary: PD-1 blocking monoclonal antibody that inhibits PD-1/PD-L1 interaction, restoring T-cell mediated anti-tumor immunity; approved for multiple advanced cancers and used here for adaptive-dose immunotherapy in Child Pugh B HCC. Source: FDA label, NCI Thesaurus.
Key Inclusion
- Histologically or AASLD-confirmed HCC diagnosis
- No prior anti-PD-1/L1 or anti-CTLA-4 therapy
- Unresectable/metastatic disease not amenable to locoregional therapy
- Child-Pugh Score B7-8
- Measurable disease per RECIST v1.1
- Age ≥18 years
- ECOG performance status 0-2
- Adequate organ and marrow function
Key Exclusion
- Prior solid organ transplant
- Hypersensitivity to IV contrast
- Active autoimmune disease requiring systemic treatment
- Uncontrolled HIV infection
- Recent prior malignancy requiring systemic treatment
- Symptomatic or active brain metastases
- Severe hypersensitivity to monoclonal antibodies
- Pregnant or nursing women
NCT07022678
A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia
Organization/Sponsor: Children's Oncology Group
Example patient: A 6-year-old boy newly diagnosed with AML, with erupted teeth, no allergies to xylitol or grapes, and no Down syndrome, planned for two cycles of cytarabine-based chemotherapy.
Phase N/A
NCT07022678
A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia
Organization/Sponsor: Children's Oncology Group
Example patient: A 6-year-old boy newly diagnosed with AML, with erupted teeth, no allergies to xylitol or grapes, and no Down syndrome, planned for two cycles of cytarabine-based chemotherapy.
Phase N/A
Interventions
-
Drug/Device: Xylitol-containing Oral Wipe
Summary: Intraoral xylitol wipe that hydrates the mouth, reduces cariogenic bacteria, and may protect oral mucosal barrier integrity to prevent bloodstream infections during chemotherapy. Source: NCI Thesaurus. -
Other: Placebo Administration
Summary: Inactive control wipe used for comparison against xylitol wipe to assess efficacy in preventing bloodstream infections. Source: NCI Thesaurus. -
Procedure: Electronic Health Record Review
Summary: Review of patient records to assess outcomes such as infection rates and oral health status. Source: NCI Thesaurus. -
Drug: Cytarabine
Summary: Antimetabolite chemotherapy that inhibits DNA synthesis and repair, causing cell death in leukemic cells during S phase; standard component of AML induction/consolidation regimens. Source: FDA label, NCI Thesaurus. -
Procedure: Biospecimen Collection
Summary: Collection of biological samples (e.g., saliva, blood) for correlative research on oral microbiome and infection risk. Source: NCI Thesaurus. -
Other: Best Practice
Summary: Standard supportive care practices for oral hygiene and infection prevention used as comparator/backbone in the trial. Source: NCI Thesaurus.
Key Inclusion
- Age 1 to 25 years
- Diagnosis of AML (WHO 2016) newly diagnosed or relapsed
- Planned to receive at least 2 consecutive myelosuppressive chemotherapy cycles with IV cytarabine
- Expected severe neutropenia duration ≥7 days per cycle
- At least one visible/erupted tooth
- Agree to avoid xylitol-containing gum/toothpaste during study
- Signed informed consent
Key Exclusion
- Down syndrome-associated AML
- Prior radiation to oral cavity/head/neck within 6 months
- Known allergy to xylitol
- Known allergy to grapes or grape flavoring
- Active oral organism-related bloodstream infection treatment
- Unable to comply with dental wipe use
NCT04085887
Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
Organization/Sponsor: Stanford University
Example patient: A 10-year-old with a suspected resectable brain tumor, normal cardiac and renal function, and no prior investigational drug exposure, scheduled for standard surgical resection.
Phase 1, Phase 2
NCT04085887
Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
Organization/Sponsor: Stanford University
Example patient: A 10-year-old with a suspected resectable brain tumor, normal cardiac and renal function, and no prior investigational drug exposure, scheduled for standard surgical resection.
Phase 1, Phase 2
Interventions
-
Imaging Agent: Panitumumab-IRDye800
Summary: Monoclonal antibody targeting EGFR conjugated to near-infrared dye IRDye800; binds EGFR-expressing tumor cells and fluoresces for intraoperative tumor visualization during neurosurgery. Source: FDA label; NCI Thesaurus. -
Imaging Device: Explorer Air camera
Summary: Imaging device used to monitor brain tumors, potentially involving focused ultrasound for enhanced tumor microenvironment access. Source: Summary of Web Search. -
Imaging Device: Pinpoint-IR9000 endoscopic/handheld device
Summary: Handheld/endoscopic infrared imaging device used to detect fluorescent-labeled tumor tissue during surgical procedures. Source: Summary of Web Search; NCI Thesaurus. -
Vaccine: PDE-NEO-II
Summary: Peptide-based personalized neoantigen vaccine designed to stimulate immune response against tumor-specific mutations in brain cancer. Source: Summary of Web Search.
Key Inclusion
- Suspected brain tumor undergoing standard-of-care surgical resection
- Eligible for resection per operating surgeon
- Age 6 months to 25 years
- Life expectancy greater than 12 weeks
Key Exclusion
- Investigational drug within 30 days prior to dosing
- Recent MI, CVA, uncontrolled CHF, or unstable angina
- History of infusion reactions to monoclonal antibodies
- Pregnant or breastfeeding
- QTc prolongation on ECG
- Abnormal electrolytes (Mg, K, Ca) below normal limits
- Serum creatinine >1.5x upper limit
- Use of Class IA/III antiarrhythmic agents
- History of interstitial pneumonitis or pulmonary fibrosis
- Tumor not resectable due to location or involvement of eloquent brain
NCT07374315
A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors
Organization/Sponsor: Washington University School of Medicine
Example patient: A 12-year-old girl with B-cell ALL currently in maintenance chemotherapy, fluent in English, living with her participating mother, able to walk briskly for five minutes, with a SCOFF score of 1 and no developmental or psychiatric conditions.
Phase N/A
NCT07374315
A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors
Organization/Sponsor: Washington University School of Medicine
Example patient: A 12-year-old girl with B-cell ALL currently in maintenance chemotherapy, fluent in English, living with her participating mother, able to walk briskly for five minutes, with a SCOFF score of 1 and no developmental or psychiatric conditions.
Phase N/A
Interventions
-
Behavioral/Educational: WashU Extended Learning Canvas
Summary: Educational platform module used in this study context; broader described mechanisms (gene editing, CAR-T) appear unrelated to this trial's behavioral focus. Source: Summary of Web Search. -
Device: FitBit Ace
Summary: Wearable activity tracker monitoring steps, heart rate, and sleep to encourage exercise and monitor physical activity in pediatric cancer survivors. Source: NCI Thesaurus; Summary of Web Search. -
Educational: NIH Educational Resources
Summary: Educational materials intended to inform patients/families about leukemia treatment and healthy lifestyle behaviors; supports behavioral intervention. Source: Summary of Web Search. -
Behavioral: Modified Guided Self-Help Family Intervention
Summary: Family-based counseling and self-help program adapted from Family Based Therapy to address weight gain and coping in leukemia survivors and caregivers. Source: Summary of Web Search.
Key Inclusion
- Diagnosis of ALL (T or B cell)
- On maintenance chemotherapy or within 6 months of completion
- Age 6-18 years
- English speaking
- Participating caregiver required
- Able to perform light exercise (5-minute brisk walk)
- No severe developmental delay or major mental illness
- Negative SCOFF disordered eating screen (if age 10+)
Key Exclusion
- Severe developmental delay/intellectual disability
- Significant mental illness (active suicidality, psychosis, mania, severe substance use)
- SCOFF score ≥2 indicating disordered eating risk
- Unable to speak/understand English
- No participating caregiver
- Unable to perform minimal exercise
NCT07551583
A Phase II Single Arm Study to Evaluate Safety and Preliminary Efficacy of Nivolumab Plus AVD in Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-stage Non-bulky Classical Hodgkin Lymphoma
Organization/Sponsor: M.D. Anderson Cancer Center
Example patient: A 15-year-old girl newly diagnosed with stage II non-bulky classical Hodgkin lymphoma, normal cardiac and organ function, no prior treatment or autoimmune disease, eligible for Nivolumab plus AVD therapy.
Phase 2
NCT07551583
A Phase II Single Arm Study to Evaluate Safety and Preliminary Efficacy of Nivolumab Plus AVD in Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-stage Non-bulky Classical Hodgkin Lymphoma
Organization/Sponsor: M.D. Anderson Cancer Center
Example patient: A 15-year-old girl newly diagnosed with stage II non-bulky classical Hodgkin lymphoma, normal cardiac and organ function, no prior treatment or autoimmune disease, eligible for Nivolumab plus AVD therapy.
Phase 2
Interventions
-
Chemotherapy: Dacarbazine
Summary: Alkylating agent that cross-links DNA, causing cell cycle arrest and apoptosis; used in combination chemotherapy for Hodgkin lymphoma. Source: FDA label, NCI Thesaurus. -
Chemotherapy: Vinblastine
Summary: Vinca alkaloid that binds tubulin, inhibiting microtubule formation and arresting cells in mitosis; used for Hodgkin lymphoma. Source: FDA label, NCI Thesaurus. -
Chemotherapy: Doxorubicin Hydrochloride
Summary: Anthracycline that intercalates DNA and inhibits topoisomerase II, blocking replication; carries cardiotoxicity risk. Source: FDA label, NCI Thesaurus. -
Immunotherapy (monoclonal antibody): Nivolumab
Summary: PD-1 immune checkpoint inhibitor that blocks PD-1/PD-L1 interaction, restoring T-cell mediated anti-tumor immunity; combined with AVD chemotherapy for Hodgkin lymphoma. Source: FDA label, NCI Thesaurus.
Key Inclusion
- Age 2-21 years
- Newly diagnosed early-stage (I/II) non-bulky (<10cm) classical Hodgkin lymphoma
- Baseline ejection fraction > 40%
- Adequate hepatic and renal function
- ECOG ≤2 / Karnofsky ≥60%
- No prior systemic lymphoma therapy (steroids exception)
- NYHA class 2B or better cardiac function
- Adequate contraception if applicable
Key Exclusion
- Weight less than 10kg
- Severe allergy to Nivo-AVD components
- Uncontrolled concurrent medical/psychiatric condition
- Active or documented autoimmune disease within 2 years
- Current immunosuppressive medication use (with exceptions)
- Active/uncontrolled HIV, HBV, or HCV infection
- Concurrent active malignancy under treatment
- Pregnant or breastfeeding
NCT07516353
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 17-year-old English-speaking patient newly diagnosed with Ewing sarcoma, currently receiving chemotherapy including anthracyclines at DFCI with curative intent and guardian consent.
Phase N/A
NCT07516353
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 17-year-old English-speaking patient newly diagnosed with Ewing sarcoma, currently receiving chemotherapy including anthracyclines at DFCI with curative intent and guardian consent.
Phase N/A
Interventions
-
Digital Health Tool: my.naviGATE Digital Tool
Summary: Mobile app providing personalized survivorship education and virtual peer navigation for AYAs with cancer, aiming to improve engagement in survivorship care through participant-reported outcomes. Source: Summary of Web Search.
Key Inclusion
- Aged 15-24
- Actively receiving cancer directed therapy for newly diagnosed cancer
- Diagnosis of sarcoma, AML, ALL/lymphoma, Hodgkin/mature B-cell lymphoma, or medulloblastoma
- Treatment includes alkylators, anthracyclines, and/or radiation
- Treated at DFCI, CNH, or RPOCH
Key Exclusion
- Unwilling or unable to give informed consent/assent
- No chance of cure per treating physician
- Relapsed or refractory disease
- Non-English-speaking or -reading
- Provider requests patient not be approached
NCT07358260
A Phase I, Open Label, Dose Escalation, Single Center Study of Autologous B7-H3.CD28Z.CART Cells in Children and Young Adults With Relapsed or Refractory Solid Tumors Expressing B7-H3 Genomic-based
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 14-year-old with relapsed neuroblastoma refractory to standard therapy, whose tumor biopsy shows strong B7-H3 expression by IHC, with normal organ function and no active infections or CNS metastases, eligible for CAR T-cell therapy.
Phase 1
NCT07358260
A Phase I, Open Label, Dose Escalation, Single Center Study of Autologous B7-H3.CD28Z.CART Cells in Children and Young Adults With Relapsed or Refractory Solid Tumors Expressing B7-H3 Genomic-based
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 14-year-old with relapsed neuroblastoma refractory to standard therapy, whose tumor biopsy shows strong B7-H3 expression by IHC, with normal organ function and no active infections or CNS metastases, eligible for CAR T-cell therapy.
Phase 1
Interventions
-
Chemotherapy (alkylating agent): Cyclophosphamide
Summary: Alkylating agent used in lymphodepletion prior to CAR T-cell infusion; cross-links DNA to inhibit replication and suppress host immune cells, facilitating CAR T-cell engraftment. Source: FDA label. -
Chemotherapy (antimetabolite): Fludarabine
Summary: Purine analog that inhibits DNA synthesis via DNA polymerase and ribonucleotide reductase inhibition; used with cyclophosphamide for lymphodepletion before CAR T-cell therapy. Source: FDA label. -
Cellular therapy (CAR T-cell): B7-H3.CD28Z.CART
Summary: Autologous CAR T-cell product engineered to target B7-H3-expressing solid tumor cells via a CD28 costimulatory domain, redirecting immune cells to kill cancer cells. Source: Summary of Web Search.
Key Inclusion
- Relapsed/refractory solid tumor with no curative options
- B7-H3 expression H score >100 by IHC
- Age 12 months to <30 years
- Lansky/Karnofsky performance status ≥50%
- Life expectancy >12 weeks
- Adequate marrow, renal, hepatic, cardiac, and pulmonary function
- Recovered from prior therapy toxicities per specified washout periods
- Adequate contraception for participants of childbearing potential
Key Exclusion
- Known active brain metastases or leptomeningeal disease
- Prior solid organ transplant
- Active uncontrolled infection
- Autoimmune disease requiring systemic immunosuppression within 2 years
- Other investigational agents concurrently
- HIV/HBV/HCV infection with detectable viral load
- Severe hypersensitivity to similar biologic agents
- Pregnant or breastfeeding
NCT06811454
A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness
Organization/Sponsor: Case Comprehensive Cancer Center
Example patient: A 52-year-old woman with stage II breast cancer, treated 1 year ago, reports moderate depressive symptoms (PHQ-9 score 12), has no suicidal ideation, speaks English, and owns a smartphone.
Phase N/A
NCT06811454
A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness
Organization/Sponsor: Case Comprehensive Cancer Center
Example patient: A 52-year-old woman with stage II breast cancer, treated 1 year ago, reports moderate depressive symptoms (PHQ-9 score 12), has no suicidal ideation, speaks English, and owns a smartphone.
Phase N/A
Interventions
-
Behavioral/Control: Enhanced Usual Care (EUC)
Summary: Standard cancer care management used as a control comparator without additional mindfulness intervention; provides baseline for evaluating digital mindfulness program efficacy. Source: Summary of Web Search. -
Digital Behavioral Intervention: MINDSET
Summary: Digital mindset-based intervention encouraging adaptive beliefs about cancer and bodily capability to reduce depressive symptoms via theory-based cognitive-emotional techniques. Source: Summary of Web Search; NCI Thesaurus.
Key Inclusion
- Mild to moderately-severe depressive symptoms (PHQ-9 5-19)
- Stage 0-III breast, prostate, or colorectal cancer
- Completed primary treatment within 2 years (excluding hormone therapy)
- Able to provide informed consent
- English literate and fluent
- Access to a web-enabled device
Key Exclusion
- PHQ-9 score <4 or >20
- Suicidal ideation (PHQ-9 item 9 >1)
- Condition requiring priority treatment (e.g., schizophrenia)
- Current or recent substance abuse
- Stage IV cancer diagnosis
- Active cancer recurrence requiring treatment
- Active mindfulness practice
- Prior formal mindfulness program participation
NCT06907485
A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration
Organization/Sponsor: University of Pittsburgh
Example patient: A 9-year-old boy with a newly diagnosed cerebellar pilocytic astrocytoma requiring surgical resection, with normal organ function and no history of porphyria or GI disease, consents to receive Gleolan before surgery.
Phase N/A
NCT06907485
A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration
Organization/Sponsor: University of Pittsburgh
Example patient: A 9-year-old boy with a newly diagnosed cerebellar pilocytic astrocytoma requiring surgical resection, with normal organ function and no history of porphyria or GI disease, consents to receive Gleolan before surgery.
Phase N/A
Interventions
-
Drug: Aminolevulinic acid hydrochloride
Summary: 5-ALA is a prodrug converted to protoporphyrin IX, which accumulates in tumor cells and fluoresces under blue light, aiding intraoperative visualization of brain tumors to improve resection; approved for glioma visualization (FDA label, NCI Thesaurus, Web Search).
Key Inclusion
- New or recurrent pediatric brain tumor requiring resection
- Specific tumor histologies (e.g., astrocytoma, medulloblastoma, ependymoma)
- Age 2-17 years 182 days
- Normal organ and marrow function
- Negative pregnancy test if applicable
- Informed consent/assent obtained
Key Exclusion
- Unable to swallow 5-ALA solution
- Brain stem tumors
- History of allergic reaction to similar compounds
- Personal or family history of porphyria
- Uncontrolled concurrent illness
- Pregnant or breastfeeding
- Prior GI perforation, diverticulitis, or peptic ulcer disease
NCT07549022
A Phase II Trial to Assess the Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor Patients With Homozygous MTAP Deletion Genomic-based
Organization/Sponsor: Case Comprehensive Cancer Center
Example patient: A 16-year-old with unresectable, biopsy-confirmed MPNST and homozygous MTAP deletion, normal organ function, Lansky score of 70, and no prior PRMT5 inhibitor or GI absorption issues.
Phase 2
NCT07549022
A Phase II Trial to Assess the Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor Patients With Homozygous MTAP Deletion Genomic-based
Organization/Sponsor: Case Comprehensive Cancer Center
Example patient: A 16-year-old with unresectable, biopsy-confirmed MPNST and homozygous MTAP deletion, normal organ function, Lansky score of 70, and no prior PRMT5 inhibitor or GI absorption issues.
Phase 2
Interventions
-
Drug: BMS-986504
Summary: Oral MTA-cooperative PRMT5 inhibitor selectively targeting MTAP-deleted cancer cells, reducing histone methylation and RNA splicing fidelity to decrease proliferation and increase apoptosis specifically in tumors lacking MTAP, sparing normal cells. Source: NCI Thesaurus.
Key Inclusion
- Age ≥12 years
- Pathologically confirmed MPNST
- Measurable, unresectable or metastatic disease
- Homozygous MTAP deletion confirmed by NGS
- Recovery from prior therapy toxicities to ≤Grade 1
- Adequate marrow, liver, and renal function
- ECOG 0-1 or Lansky/Karnofsky ≥50
- Effective contraception for individuals of childbearing potential
Key Exclusion
- Prior PRMT5 inhibitor treatment
- Unable to swallow tablets
- GI disease affecting drug absorption
- Active drug use
- Recent or concurrent botanical/herbal supplement use
- Need for strong CYP3A4/P-gp inhibitor, inducer, or PPI
NCT07680439
A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma
Organization/Sponsor: BrainChild Bio, Inc
Example patient: A 7-year-old girl with DIPG confirmed by MRI, who completed radiation therapy 4 weeks ago, has a CNS reservoir catheter, stable neurologic status, and no metastatic disease or other exclusions.
Phase 2
NCT07680439
A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma
Organization/Sponsor: BrainChild Bio, Inc
Example patient: A 7-year-old girl with DIPG confirmed by MRI, who completed radiation therapy 4 weeks ago, has a CNS reservoir catheter, stable neurologic status, and no metastatic disease or other exclusions.
Phase 2
Interventions
-
Biological/CAR T Cell Therapy: BCB-276
Summary: BCB-276 is an autologous CAR T cell therapy targeting B7-H3, delivered locoregionally to the CNS to treat DIPG, a pediatric high-grade glioma; has FDA breakthrough designation. Source: Summary of Web Search.
Key Inclusion
- Age 1 to 26 years, weight ≥10kg
- Diagnosis of DIPG by imaging (with or without biopsy)
- Able to tolerate leukapheresis and study procedures
- CNS reservoir catheter present prior to first dose
- Completed standard radiation therapy within 6 weeks of enrollment
- Performance status ≥60 (Lansky/Karnofsky)
- Adequate organ function and stable/improving neurologic symptoms
- Programmable VP shunt if present, tolerant to adjustment
Key Exclusion
- Previous tumor-directed therapy besides standard radiation/temozolomide
- Evidence of metastatic disease
- High or increasing corticosteroid requirement
- Severe swallowing difficulties or interfering conditions
- Active malignancy other than DIPG
- Active/uncontrolled HIV, hepatitis B or C
- Pregnant or breastfeeding
- Any condition prohibiting protocol treatment per investigator
NCT07662824
Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study
Organization/Sponsor: Mayo Clinic
Example patient: A 45-year-old English-speaking woman treated with pelvic radiation for cervical cancer 6 months ago, now with stress urinary incontinence, able to use a smartphone and tolerate vaginal device insertion without pain.
Phase N/A
NCT07662824
Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study
Organization/Sponsor: Mayo Clinic
Example patient: A 45-year-old English-speaking woman treated with pelvic radiation for cervical cancer 6 months ago, now with stress urinary incontinence, able to use a smartphone and tolerate vaginal device insertion without pain.
Phase N/A
Interventions
-
Procedure: Referral
Summary: Sending a patient to another practitioner for care; used here as part of study workflow, not a targeted cancer therapy. Source: NCI Thesaurus. -
Other: Questionnaire Administration
Summary: Administration of self-report questionnaires to assess patient-reported outcomes such as urinary symptoms and quality of life; no biological mechanism. Source: NCI Thesaurus. -
Device: Flyte Medical Device Usage and Evaluation
Summary: Non-invasive intravaginal mechanotherapy device that stimulates pelvic floor muscle contraction to improve urinary incontinence/overactive bladder symptoms in pelvic radiation survivors. Source: Summary of Web Search; NCI Thesaurus. -
Other: Interview
Summary: Qualitative conversational data collection to capture patient experience with device usability and symptom impact. Source: NCI Thesaurus. -
Behavioral: Educational Intervention
Summary: Educational activity to inform patients about pelvic floor therapy and device use, supporting adherence and symptom management. Source: NCI Thesaurus; Summary of Web Search.
Key Inclusion
- Female, prior pelvic radiation for endometrial or cervical cancer ≥3 months prior
- Age ≥21 years
- English speaking
- Signed informed consent
- Diagnosis of urinary incontinence (SUI/UUI/mixed) or OAB
- Able to contract pelvic floor muscles without pain
- Able to tolerate size 6 vaginal dilator
- Smartphone/tablet access for Flyte app
Key Exclusion
- Concurrent participation in interfering clinical study
- Active cytotoxic chemotherapy post-hysterectomy
- Radiation or surgery completed within 3 months
- Life expectancy <6 months
- Unable to tolerate vaginal wand insertion
- Suspected vesicovaginal/colovaginal fistula
- Physical or cognitive limitations preventing device use
- Acute infection or hematuria
NCT07346157
PNOC044: Liothyronine (L-T3) in Combination With Bevacizumab, Irinotecan and Temozolomide (BIT) for Progressive or Relapsed Medulloblastoma (Cohort 1) or as Monotherapy for Medulloblastoma With Minimal Residual Disease (Cohort 2) Genomic-based
Organization/Sponsor: University of California, San Francisco
Example patient: A 10-year-old with relapsed medulloblastoma after craniospinal radiation, Lansky score 70, normal organ and cardiac function, no recent chemotherapy, eligible for BIT plus L-T3 therapy.
Phase 1, Phase 2
NCT07346157
PNOC044: Liothyronine (L-T3) in Combination With Bevacizumab, Irinotecan and Temozolomide (BIT) for Progressive or Relapsed Medulloblastoma (Cohort 1) or as Monotherapy for Medulloblastoma With Minimal Residual Disease (Cohort 2) Genomic-based
Organization/Sponsor: University of California, San Francisco
Example patient: A 10-year-old with relapsed medulloblastoma after craniospinal radiation, Lansky score 70, normal organ and cardiac function, no recent chemotherapy, eligible for BIT plus L-T3 therapy.
Phase 1, Phase 2
Interventions
-
Chemotherapy (alkylating agent): Temozolomide (TMZ)
Summary: Oral alkylating agent that methylates DNA at guanine residues, inhibiting DNA replication and causing tumor cell death; used with irinotecan and bevacizumab (BIT) for relapsed medulloblastoma. Source: FDA label, NCI Thesaurus. -
Chemotherapy (topoisomerase I inhibitor): Irinotecan
Summary: Prodrug converted to SN-38, which inhibits topoisomerase I causing DNA strand breaks and apoptosis; combined with TMZ and bevacizumab in BIT regimen. Source: FDA label, NCI Thesaurus. -
Monoclonal antibody (anti-angiogenic): Bevacizumab
Summary: Humanized monoclonal antibody blocking VEGF to inhibit tumor angiogenesis; used as part of BIT regimen for relapsed/progressive medulloblastoma. Source: FDA label, NCI Thesaurus. -
Thyroid hormone (investigational adjunct): Liothyronine (L-T3)
Summary: Synthetic T3 thyroid hormone binding nuclear receptors to modulate gene expression; being tested for potential anti-tumor synergy with BIT or as monotherapy in minimal residual disease. Source: FDA label, NCI Thesaurus.
Key Inclusion
- Histologically confirmed medulloblastoma, relapsed/progressive (Cohort 1) or cf-DNA positive CSF (Cohort 2)
- Age 1-25 years
- Karnofsky/Lansky performance score ≥50
- Adequate organ function (ANC, platelets, renal, hepatic)
- Normal or controlled adrenal and cardiac function
- Received standard upfront therapy (radiation or high-dose chemo with stem cell rescue)
- Stable levothyroxine dosing ≥3 months if applicable
- Willing to use contraception during and after treatment
Key Exclusion
- Prior treatment with BIT combination (Cohort 1)
- Recent myelosuppressive chemotherapy or biologic therapy without recovery
- Uncontrolled cardiovascular disease or arrhythmia
- Uncontrolled hypertension or diabetes
- Pregnant or breastfeeding
- Graves' disease or hyperthyroidism
- HIV positive with unstable regimen
- Use of strong CYP450 inhibitors/inducers
NCT07681791
A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
Organization/Sponsor: Rutgers, The State University of New Jersey
Example patient: A 15-year-old English-speaking girl who got sunburned last summer lives full-time with her mother, who has Facebook and daily internet access, and both have smartphones and no melanoma history.
Phase N/A
NCT07681791
A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
Organization/Sponsor: Rutgers, The State University of New Jersey
Example patient: A 15-year-old English-speaking girl who got sunburned last summer lives full-time with her mother, who has Facebook and daily internet access, and both have smartphones and no melanoma history.
Phase N/A
Interventions
-
Behavioral: Parent Facebook
Summary: Digital intervention delivered via Facebook to parents aimed at promoting sun protection behaviors and skin cancer prevention in their teens; described generically as a supportive engagement tool (Source: Summary of Web Search). -
Behavioral: Teen MMS
Summary: Mobile messaging service (MMS) intervention delivering skin cancer prevention messaging directly to teens via smartphone, intended to improve sun protection behaviors (Source: Summary of Web Search).
Key Inclusion
- Parent-teen dyads required
- Teens aged 13-17
- Lives with study parent >=half time in US
- History of sunburn, indoor tanning, or suboptimal sun protection
- No personal history of melanoma
- Access to smartphone
- Parent has Facebook account and daily internet access
- English speaking and reading
Key Exclusion
- Severe medical condition preventing participation
- Personal history of melanoma
- No smartphone access
- Non-English speakers
- No internet/Facebook access (parent)
- Teen not living with parent at least half time
NCT06623305
Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
Organization/Sponsor: Medical College of Wisconsin
Example patient: A 7-year-old English-speaking child with acute lymphoblastic leukemia admitted to the oncology unit receiving high-dose methotrexate (5 g/m2), without current severe mucositis or BMT admission.
Phase N/A
NCT06623305
Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
Organization/Sponsor: Medical College of Wisconsin
Example patient: A 7-year-old English-speaking child with acute lymphoblastic leukemia admitted to the oncology unit receiving high-dose methotrexate (5 g/m2), without current severe mucositis or BMT admission.
Phase N/A
Interventions
-
Device/Therapy: Photobiomodulation for exploratory arm
Summary: Low-level light therapy used to reduce inflammation and pain and promote healing; explored for managing mucositis side effects in pediatric oncology patients. Source: Summary of Web Search. -
Device/Therapy: Photobiomodulation for prevention arm
Summary: Low-level laser/LED therapy targeting mitochondrial chromophores to enhance ATP production, reduce inflammation and pain, used preventively against oral mucositis. Source: Summary of Web Search. -
Device/Therapy: Photobiomodulation
Summary: Non-ionizing light therapy (400-1100nm) causing nonthermal cellular responses via mitochondrial mechanisms, reducing pain/inflammation and speeding healing. Source: NCI Thesaurus.
Key Inclusion
- Ages 0-30
- Admitted to CW oncology/BMT inpatient unit, PICU, or West 5
- Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21)
- OR Anthracycline ≥60 mg/m2
- Able to speak/understand English or Spanish
- New or current diagnosis, consented upon admission
Key Exclusion
- Admitted on BMT service
- CTCAE grade 4 oral mucositis or higher at time of enrollment
NCT07436611
Rapamycin Dose-Ranging Efficacy Study: A Phase II, Proof of Concept, Double-blind, Placebo-controlled, Randomized, Parallel-group, Dose-response Comparison of the Effects of Different Strengths of Rapamycin Cream Applied Topically in Subjects Diagnosed With Port Wine Stains
Organization/Sponsor: AFT Pharmaceuticals, Ltd.
Example patient: A 6-year-old boy with a 6cm facial port-wine stain, Fitzpatrick skin type III, previously responsive to PDL with purpura, and no recent laser or immunosuppressive therapy, enrolls in the trial.
Phase 2
NCT07436611
Rapamycin Dose-Ranging Efficacy Study: A Phase II, Proof of Concept, Double-blind, Placebo-controlled, Randomized, Parallel-group, Dose-response Comparison of the Effects of Different Strengths of Rapamycin Cream Applied Topically in Subjects Diagnosed With Port Wine Stains
Organization/Sponsor: AFT Pharmaceuticals, Ltd.
Example patient: A 6-year-old boy with a 6cm facial port-wine stain, Fitzpatrick skin type III, previously responsive to PDL with purpura, and no recent laser or immunosuppressive therapy, enrolls in the trial.
Phase 2
Interventions
-
Device/Procedure: Pulsed dyed laser
Summary: PDL targets blood vessels via photothermolysis, inducing purpura/blanching to treat vascular lesions like port-wine stains; used adjunctively in this trial. Source: Summary of Web Search; NCI Thesaurus. -
Drug: Rapamycin cream
Summary: Topical mTOR inhibitor cream studied for reducing vascular proliferation in port-wine stains, potentially enhancing PDL response by inhibiting angiogenesis and cell growth. Source: Summary of Web Search.
Key Inclusion
- Age ≤10 years
- Facial, neck, or upper trunk port-wine stain
- PWS size ≥5cm x 2.5cm
- Fitzpatrick skin type I-IV
- Indicated for and accepting PDL treatment
- Responds to PDL with purpura or blanching
- Able to maintain patient diaries
- Willing to apply cream only to part of PWS
Key Exclusion
- Fitzpatrick skin type V or VI
- PWS in extremities/acral areas
- Serious skin lesions (erosions/ulcers)
- Hypersensitivity to study product components
- Recent rapamycin/sirolimus/everolimus/temsirolimus use
- Recent laser or surgical PWS therapy
- 5+ prior PDL treatments
- Immune dysfunction or immunosuppression
NCT07521657
Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma Genomic-based
Organization/Sponsor: University of Alabama at Birmingham
Example patient: A 14-year-old with NF1 and newly diagnosed TP53-mutant high-grade glioma, good performance status, and normal organ function, with no prior MEK inhibitor or radiation therapy, meeting all trial criteria.
Phase N/A
NCT07521657
Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma Genomic-based
Organization/Sponsor: University of Alabama at Birmingham
Example patient: A 14-year-old with NF1 and newly diagnosed TP53-mutant high-grade glioma, good performance status, and normal organ function, with no prior MEK inhibitor or radiation therapy, meeting all trial criteria.
Phase N/A
Interventions
-
Drug: mirdametinib
Summary: Oral MEK1/2 inhibitor that blocks RAS/RAF/MEK/ERK signaling, reducing tumor proliferation; FDA-approved for NF1-associated plexiform neurofibromas, used here for NF1-altered high-grade glioma. Source: FDA label, NCI Thesaurus, Web Search. -
Drug + Radiation: mirdametinib with radiation
Summary: Combination of MEK inhibitor mirdametinib with radiotherapy intended to enhance tumor control in NF1-related high-grade glioma via combined pathway inhibition and cytotoxic radiation effect. Source: Web Search.
Key Inclusion
- GBM IDH-wildtype grade 4 or HGG with NF1 alteration/TP53 mutation
- Cohort-specific NF1 diagnosis status
- Age >=18 (Cohort1) or >=12 (Cohorts2/3)
- Karnofsky/Lansky performance status >=60
- Adequate bone marrow, renal, liver function
- Archival tumor tissue available
- Required washout intervals from prior therapy/radiation
- Stable or decreasing corticosteroid dose
Key Exclusion
- IDH-mutant, H3.1/H3.3 mutant, or BRAF-altered tumor
- Unresolved >Grade1 toxicity from prior therapy
- Prior MEK inhibitor therapy for glioma
- Significant cardiovascular disease or QTc >450msec
- GI dysfunction affecting drug absorption
- Recent thromboembolic/cerebrovascular event
- Concurrent malignancy requiring treatment
- Ophthalmologic conditions (e.g., retinopathy, glaucoma)
NCT07223463
A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer
Organization/Sponsor: Children's Hospital Medical Center, Cincinnati
Example patient: A 17-year-old English-speaking girl with leukemia, prescribed oral chemotherapy, with normal cognition and 80% adherence during the run-in period, willing to use the electronic monitoring device.
Phase N/A
NCT07223463
A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer
Organization/Sponsor: Children's Hospital Medical Center, Cincinnati
Example patient: A 17-year-old English-speaking girl with leukemia, prescribed oral chemotherapy, with normal cognition and 80% adherence during the run-in period, willing to use the electronic monitoring device.
Phase N/A
Interventions
-
Behavioral/Standard of Care: Feedback Program (Uniform Standard of Care)
Summary: A standardized feedback and quality-improvement program aiming to improve pediatric cancer care and reduce disparities in outcomes. Source: Summary of Web Search. -
Behavioral/Adherence Intervention: Tailored Program
Summary: An individualized behavioral intervention adapting communication and support strategies to improve medication adherence based on patient-specific factors. Source: Summary of Web Search; NCI Thesaurus.
Key Inclusion
- Age 15.00 to 24.99 years
- Diagnosed with cancer
- Prescribed an oral anticancer/antitumor agent or prophylaxis
Key Exclusion
- Not fluent in English
- Significant cognitive deficits
- Medical status or treatment precludes participation
- Enrolled on trial requiring trial-provided medication container
- Adherence ≥95% during run-in period
- Declines or has difficulty using electronic adherence monitoring device
NCT07573111
An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation
Organization/Sponsor: Laguna Biotherapeutics, Inc.
Example patient: A 12-year-old with high-risk acute leukemia who received an HLA-partially matched TCRαβ/CD19-depleted HSCT, achieved engraftment, has a Lansky score of 80, and has no active GVHD or device implants.
Phase 1
NCT07573111
An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation
Organization/Sponsor: Laguna Biotherapeutics, Inc.
Example patient: A 12-year-old with high-risk acute leukemia who received an HLA-partially matched TCRαβ/CD19-depleted HSCT, achieved engraftment, has a Lansky score of 80, and has no active GVHD or device implants.
Phase 1
Interventions
-
Biological: QUAIL-100
Summary: Investigational biological agent (possibly Listeria-based) for high-risk leukemias/MDS post-HSCT; exact mechanism undisclosed; first-in-human dose escalation study. Source: Summary of Web Search.
Key Inclusion
- Weight >= 10 kg
- Received HLA-partially matched HSCT for high-risk malignant disease
- Achieved myeloid and platelet engraftment
- Lansky/Karnofsky score > 60
- Agree to contraception if of childbearing potential
Key Exclusion
- Active Grade II aGVHD requiring high-dose steroids or Grade III/IV aGVHD
- Significant organ or immunological disease compromising safety
- Allergy to both amoxicillin and gentamycin
- Implanted devices with high infection risk
- Planned anti-leukemic therapy within 21 days
- TNF-alpha or PI3K inhibitor use within 60 days
- Prior investigational Listeria product exposure
- Live attenuated vaccine within 4 weeks
NCT07061626
A Two-Part, Phase 1/2a Trial to Determine the Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Delivered Via Convection Enhanced Delivery (CED) in Supratentorial Recurrent, Refractory, or Progressive Pediatric Ependymoma and High-Grade Glioma (HGG)
Organization/Sponsor: Cerenome
Example patient: A 10-year-old boy with recurrent supratentorial glioblastoma, KPS 80, normal organ function, and a single 3 cm lesion away from critical structures, eligible for CED-based rhenium-186 nanoliposome therapy.
Phase 1, Phase 2a
NCT07061626
A Two-Part, Phase 1/2a Trial to Determine the Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Delivered Via Convection Enhanced Delivery (CED) in Supratentorial Recurrent, Refractory, or Progressive Pediatric Ependymoma and High-Grade Glioma (HGG)
Organization/Sponsor: Cerenome
Example patient: A 10-year-old boy with recurrent supratentorial glioblastoma, KPS 80, normal organ function, and a single 3 cm lesion away from critical structures, eligible for CED-based rhenium-186 nanoliposome therapy.
Phase 1, Phase 2a
Interventions
-
Radiotherapeutic Nanoliposome: Rhenium-186 Nanoliposome (186RNL, Rhenium Obisbemeda)
Summary: A radiolabeled nanoliposome delivering high-dose Rhenium-186 radiation directly into tumor tissue via convection-enhanced delivery (CED), minimizing damage to surrounding healthy brain tissue; being tested for safety and efficacy in pediatric recurrent/refractory ependymoma and high-grade glioma. Source: Summary of Web Search.
Key Inclusion
- Age 6-21 years (up to 25 on case-by-case basis)
- Single or limited multiple supratentorial lesions ≤3.5 cm and ≤22.4 mL
- Recurrent, refractory, or progressive ependymoma or high-grade glioma
- Not eligible for resection or off standard-of-care
- Karnofsky/Lansky performance status ≥60
- Adequate liver, renal, and hematologic function
- Negative pregnancy test and effective contraception
- Life expectancy ≥2 months
Key Exclusion
- Spinal disease or infratentorial tumor location
- Leptomeningeal involvement
- Serious intercurrent illness (cardiac, infectious, hypertensive, etc.)
- Recent Bevacizumab, radiation, or systemic anticancer therapy
- Tumor within 1.0 cm of ventricle or 1.5 cm of critical structures
- Acute intracranial or intratumoral hemorrhage
- Unstable antiepileptic or corticosteroid regimen
- Psychiatric/social issues limiting compliance
NCT07662239
Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 17-year-old sarcoma survivor treated at the DFCI Sarcoma Center, medically stable, sedentary, fluent in English, with parental consent to join the personalized exercise program.
Phase N/A
NCT07662239
Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 17-year-old sarcoma survivor treated at the DFCI Sarcoma Center, medically stable, sedentary, fluent in English, with parental consent to join the personalized exercise program.
Phase N/A
Interventions
-
Behavioral/Exercise Intervention: Exercise Triage and Personalized Exercise Program
Summary: A personalized, non-drug exercise intervention designed to improve physical function and well-being in AYA sarcoma survivors, using individualized triage and tailored exercise sessions with trained staff. Source: Summary of Web Search.
Key Inclusion
- Diagnosed with bone or soft tissue sarcoma
- Age 15-39 at diagnosis
- Age 15 or older at enrollment
- Established patient of DFCI Sarcoma Center or Jimmy Fund
- Able to read and understand English
- Assent/consent for minors 15-17
Key Exclusion
- Unstable cardiovascular disease in last 6 months
- Untreated psychiatric disorders or substance use disorder
- Pregnant
- Currently in physical or occupational therapy
- Medical conditions/medications prohibiting exercise
- Already meeting exercise guidelines (150 min moderate/75 min vigorous plus strength training)
- Adults unable to consent
NCT07514819
Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
Organization/Sponsor: St. Jude Children's Research Hospital
Example patient: A 12-year-old with newly diagnosed Ewing sarcoma is scheduled for 15 fractions of proton radiation therapy at St. Jude with consent provided by her parents.
Phase N/A
NCT07514819
Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
Organization/Sponsor: St. Jude Children's Research Hospital
Example patient: A 12-year-old with newly diagnosed Ewing sarcoma is scheduled for 15 fractions of proton radiation therapy at St. Jude with consent provided by her parents.
Phase N/A
Interventions
-
Radiation Therapy: Proton Therapy (Adaptive)
Summary: Adaptive proton therapy delivers high-energy proton beams precisely targeting tumors while sparing healthy tissue, adjusting treatment plans over time based on imaging feedback to optimize dose delivery in pediatric cancer patients. Source: NCI Thesaurus, Summary of Web Search.
Key Inclusion
- Diagnosed with solid tumors (rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, other sarcomas/carcinomas)
- Diagnosed with Hodgkin's lymphoma
- Receiving proton radiation therapy at St. Jude
- Written informed consent obtained
Key Exclusion
- Not diagnosed with solid tumor or Hodgkin's lymphoma
- Diagnosed with Wilm's tumor or neuroblastoma
- Not undergoing proton therapy
- Prescribed 5 or fewer fractions of proton therapy
- Severe comorbid conditions affecting imaging feasibility
- Unable to obtain consent
- Pregnant or breastfeeding females