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Monthly Update Report for Trials Started in February 2026


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1: Summary data from new trials identified for Brain Cancer.


Overview

Number of Trials: 9

These nine trials focus on brain tumors, brain metastases, and advanced cancer symptom management. Most target primary brain tumors (gliomas, glioblastoma) or brain metastases from solid cancers, particularly breast cancer. Interventions range from novel imaging agents and antibody-drug conjugates to exercise programs, mobile health apps, and radiation therapy techniques. Several trials explore surgical resection with tissue collection or intraoperative imaging. One trial evaluates MRI surveillance for early detection of brain metastases in stage IV breast cancer patients.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Ability to provide informed consent
  • Performance status (ECOG ≤2 or KPS ≥60-70)
  • Adequate organ function (liver, kidney, bone marrow)
  • Histologically or radiographically confirmed cancer diagnosis
  • Willingness to comply with study procedures

Common Exclusion

  • Pregnancy or breastfeeding
  • Active uncontrolled infection
  • Severe cardiac disease or recent cardiac event
  • Leptomeningeal disease
  • Contraindication to MRI with contrast
  • Severe psychiatric or cognitive impairment
  • Recent major surgery or radiation therapy (within specified timeframes)
  • Concurrent investigational agents (in some trials)

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07332377

PsyMINT: Mobile Health (mHealth) Intervention to Support Self-Management of Pain and Symptoms for Cancer Survivors

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 45-year-old English-speaking breast cancer survivor in complete remission for two years experiencing chronic treatment-related neuropathic pain, not taking psychiatric medications and not pregnant.

Phase N/A

Interventions

  • Behavioral: Mobile Health (mHealth) Intervention
    Summary: Mobile technology-based intervention designed to support self-management of pain and symptoms in cancer survivors through remote monitoring and patient-provider communication (Source: Web Search Summary).

Key Inclusion

  • Post-treatment stage with no evidence of disease (complete remission)
  • Diagnosed with cancer in the past three years
  • Experiencing cancer/treatment-related pain
  • 18 years of age or older at first diagnosis
  • Cognitively able to participate in online-based study
  • Able to read, write, and understand English

Key Exclusion

  • Currently use medication for psychiatric reasons (stimulants, mood stabilizers)
  • Major psychotic disorders (bipolar disorder or schizophrenia)
  • Substance use disorders
  • Currently pregnant or planning pregnancy in next three months

NCT07278440

ET-NEURO: A Pilot Trial of the Exercise Together Program in Primary Brain Tumor Patient-Caregiver Dyads Incorporating Glymphatic MRI

Organization/Sponsor: OHSU Knight Cancer Institute


Example patient: A 52-year-old man with WHO grade 3 astrocytoma, 10 weeks post-craniotomy and 8 weeks post-radiation, Karnofsky score 80, living with his wife who will serve as his caregiver partner.

Phase N/A

Interventions

  • Behavioral: Resistance Training
    Summary: Physical exercise using weight or resistance to induce muscle contraction, building strength and skeletal muscle size through exercises like leg press, chest press, and bicep curls (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Collection of patient self-reported outcomes to assess quality of life, psychological and physical impacts, and treatment effects through structured questionnaires (NCI Thesaurus, Web Search).
  • Diagnostic: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed pictures of internal organs and tissues, valuable for diagnosing and monitoring brain tumors (NCI Thesaurus).
  • Other: Electronic Health Record Review
    Summary: Analysis of patient data from electronic health records to assess clinical information, improve care coordination, and monitor patient outcomes (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed WHO grade 1-4 primary brain tumor
  • At least 6 weeks post-radiation therapy
  • At least 8 weeks post-craniotomy
  • Co-residing spouse or partner caregiver
  • Karnofsky performance score at least 70 or ECOG score 1 or less
  • Age 18 years or older
  • Home internet sufficient for videoconferencing
  • Oral chemotherapy allowed

Key Exclusion

  • Regular strength training two or more sessions per week in past 30 days
  • Cognitive difficulties precluding survey completion
  • Pregnant or planning pregnancy
  • Poorly controlled diabetes or recent cardiac event
  • Severe balance disorder or inability to ambulate without walker or wheelchair
  • Inability to stand for 3 minutes
  • New focal deficits concerning for recurrent or progressive tumor
  • Severe hearing or vision problems

NCT07374692

Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors Genomic-based

Organization/Sponsor: National Institutes of Health Clinical Center (CC)


Example patient: A 42-year-old patient with recurrent IDH-wild-type glioblastoma scheduled for surgical resection at NIH, 8 months after completing radiation therapy.

Phase N/A

Interventions

  • Procedure: Tumor sample collection
    Summary: Gathering biospecimens for testing, diagnostic, propagation, treatment or research purposes (NCI Thesaurus).

Key Inclusion

  • Advanced CNS tumors confirmed by documented pathology report
  • Recurrent IDH-wild-type high-grade glioma
  • Recurrent IDH-mutant gliomas
  • Other recurrent CNS tumors
  • Scheduled for brain tumor biopsy or resection
  • Biopsy or resection at least 6 months after previous radiation therapy if applicable
  • Age 15 years or older
  • Procedures planned at NIH

Key Exclusion

  • None

NCT07227610

Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

Organization/Sponsor: Medical University of South Carolina


Example patient: A 62-year-old woman with metastatic lung cancer and a 3.5 cm brain metastasis in the right frontal lobe, KPS 70, neurologically stable without leptomeningeal disease, no prior brain radiation.

Phase N/A

Interventions

  • Radiation: Fractionated Stereotactic Radiotherapy (FSRT)
    Summary: Stereotactic radiation therapy delivering multiple doses of radiation spread over several treatment sessions (NCI Thesaurus).
  • Radiation: Staged Stereotactic Radiosurgery (SSRS)
    Summary: Stereotactic radiation therapy delivering multiple doses of radiation spread over several treatment sessions (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • Karnofsky Performance Status ≥60
  • Brain metastasis measuring ≥2 cm and ≤5 cm in maximum diameter
  • Known active or history of invasive non-CNS primary cancer within past 3 years
  • Neurologically stable, immediate surgery not necessary
  • Up to 10 additional smaller metastases (<2 cm) allowed
  • All tumors must be ≥5mm from optic chiasm and optic nerves
  • Negative pregnancy test within 7 days for persons of childbearing potential

Key Exclusion

  • Prior cranial radiotherapy including WBRT or SRS in area of large metastasis
  • Evidence of leptomeningeal disease
  • Inability to undergo MRI with contrast
  • Planned systemic therapy within 3 days before, day of, or 3 days after SRS

NCT07089758

A Pilot Feasibility Study for Cerebral Open Flow Microperfusion in Patients Undergoing Planned Neurosurgical Resection of Diseased Parenchyma.

Organization/Sponsor: Mayo Clinic


Example patient: A 52-year-old male with ECOG performance status 1 and radiographic evidence of WHO grade III glioma scheduled for surgical resection at Mayo Clinic Rochester.

Phase N/A

Interventions

  • Device: Cerebral open flow microperfusion
    Summary: Cerebral open flow microperfusion (cOFM) continuously samples brain tissue interstitial fluid to measure substance transport across the blood-brain barrier, tested for safety and feasibility in brain cancer treatment (Web Search).

Key Inclusion

  • ECOG performance status 0, 1 or 2
  • Clinical and radiographic diagnosis of glioma WHO grade II-IV
  • Prior diagnosis of glioma suspected WHO grade II-IV
  • Clinical evidence of epileptic foci requiring temporal lobectomy
  • Clinical indication for resection as routine clinical care
  • Surgery planned at Mayo Clinic Rochester MN
  • Able to provide informed consent or legally authorized representative

Key Exclusion

  • Pregnant women
  • Prisoners
  • Mentally handicapped
  • Not appropriate candidates for surgery due to medical history
  • Uncontrolled concurrent illness
  • Deemed at increased risk of adverse effects by surgeon

NCT07063693

Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma

Organization/Sponsor: Dartmouth-Hitchcock Medical Center


Example patient: A 52-year-old man with imaging-confirmed high-grade glioma scheduled for surgical resection, with normal kidney and liver function, not on any EGFR-targeted therapies.

Phase 1

Interventions

  • Drug: ABY-029
    Summary: A fluorescence imaging agent composed of an EGFR-targeting affibody molecule labeled with IRDye 800CW near-infrared fluorescent probe. It binds to EGFR-overexpressing tumor cells enabling visualization during surgery. Source: NCI Thesaurus.

Key Inclusion

  • Clinical diagnosis of presumed high-grade glioma based on imaging
  • Tumor suitable for open cranial resection
  • Age 18 years or older
  • Valid informed consent
  • Ability to understand and sign written informed consent

Key Exclusion

  • Prisoners
  • Pregnant or breast feeding
  • On experimental or approved anti-EGFR targeted therapies
  • Elevated kidney or liver function tests greater than 2.5 times normal limit
  • Any condition contraindicating research participation per investigator

NCT07102212

Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking woman with stage IV breast cancer experiencing moderate insomnia and fatigue, who uses email regularly and has an ECOG performance status of 1.

Phase N/A

Interventions

  • Behavioral: mHealth Intervention
    Summary: Mobile technology-based intervention using telemedicine to address symptom clusters including insomnia, depression, anxiety, and fatigue in advanced cancer patients, offering personalized support and tracking (Web Search, NCI Thesaurus).

Key Inclusion

  • Advanced cancer (stage IIIb/c or IV lung, stage IV breast, stage IV prostate, advanced multiple myeloma, stage IIIb/IV melanoma)
  • Age 18 years or older
  • Able to read and write in English
  • Use internet and email
  • Meet clinical cut-offs on at least two symptoms: insomnia (ISI ≥8), depression (PHQ-2 ≥3), anxiety (GAD-2 ≥2), or fatigue (FSI ≥3)

Key Exclusion

  • Night-shift work
  • Untreated bipolar disorder
  • Substance use disorder
  • Cognitive impairment per Brief Screen for Cognitive Impairment
  • ECOG performance status 3 or greater (in bed 50% or more of day)
  • Less than 6 months predicted survival

NCT07268053

A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases

Organization/Sponsor: St. Joseph's Hospital and Medical Center, Phoenix


Example patient: A 52-year-old with recurrent glioblastoma after surgery and chemoradiation, ECOG 1, with a 1.5 cm contrast-enhancing lesion, adequate organ function, on stable dexamethasone 6 mg daily, and no cardiac or pulmonary comorbidities.

Phase 0, Phase 1

Interventions

  • Drug: Risvutatug rezetecan
    Summary: B7-H3-targeted antibody-drug conjugate that delivers cytotoxic agents directly to cancer cells expressing B7-H3 protein, investigated for brain cancer and solid tumors with promising anti-tumor activity in early trials (Web Search).

Key Inclusion

  • GBM per 2021 WHO criteria progressed after standard therapy including maximal safe resection and concurrent chemoradiation, or brain metastasis requiring resection with controlled systemic disease
  • Measurable disease with at least one contrast-enhancing lesion ≥1 cm in two perpendicular measurements
  • Age ≥18 years
  • ECOG performance status ≤2
  • Adequate bone marrow function: ANC ≥1500/μL, platelets ≥100,000/μL, hemoglobin ≥9.0 g/dL
  • Adequate hepatic function: bilirubin ≤1.5x ULN, AST/ALT ≤2.5x ULN
  • Adequate renal function: eGFR ≥50 mL/min/1.73 m²
  • Archival or biopsy brain tumor tissue available

Key Exclusion

  • Leptomeningeal metastasis or spinal cord compression
  • Active systemic bacterial, fungal, or viral infection requiring treatment
  • Prior treatment with B7-H3 targeted agents including orlotamab, enoblituzumab, or I-Dxd
  • Investigational agent within 4 weeks or cytotoxic chemotherapy within 14 days of first infusion
  • Current interstitial lung disease or pneumonitis, or history requiring high-dose glucocorticoids
  • QTc >450 msec or LVEF <50%
  • Myocardial infarction, unstable angina, CVA, or CHF Class III/IV within 6 months
  • Arteriovenous thromboembolic events within 3 months

NCT07357298

Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer Genomic-based

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 52-year-old woman with newly diagnosed HR+/HER2- stage IV breast cancer with bone and liver metastases, ECOG status 1, no neurologic symptoms, and normal renal function starting first-line endocrine therapy.

Phase III

Interventions

  • Procedure: Standard of Care Brain Imaging
    Summary: Standard of care brain imaging uses MRI surveillance to detect brain metastases in asymptomatic stage IV breast cancer patients, relying on high-resolution imaging to identify cancerous spread (Summary of Web Search).
  • Procedure: Surveillance Brain MRI
    Summary: Surveillance Brain MRI involves regular scans every 6 months to detect brain metastases early in breast cancer, potentially altering treatment strategies (Summary of Web Search).

Key Inclusion

  • Histologic diagnosis of breast cancer with ER/PR/HER2 status documentation
  • Radiographic evidence of stage IV extracranial disease
  • Enrolled within 60 days of diagnosis or starting first line therapy
  • HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy
  • Age ≥ 18 years
  • Life expectancy ≥ 6 months
  • ECOG performance status ≤ 2

Key Exclusion

  • Prior diagnosis or treatment of brain metastases or leptomeningeal disease
  • History of other non-breast malignancy requiring treatment
  • Neurologic symptoms warranting standard screening brain MRI
  • Indications warranting brain MRI for other neurologic conditions
  • Contraindication towards MRI with contrast
  • Chronic kidney disease stage IV or V or CrCl <30 ml/min