Selumetinib for Pediatric Brain Cancer

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen by Jason R Fangusaro

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and the best dose of selumetinib and how well it works in treating or re-treating young patients with low grade glioma that has come back (recurrent) or does not respond to treatment (refractory). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Jason R Fangusaro

Principal Investigator

Pediatric Brain Tumor Consortium

Eligibility Criteria

This trial is for young patients aged 3-21 with recurrent or refractory low grade glioma, including various types of brain tumors like astrocytoma. Participants must have specific tumor characteristics confirmed by recent tests and be willing to provide tissue samples for genetic testing.

Inclusion Criteria

Absolute neutrophil count >= 1,000/uL (unsupported) (within 14 days of registration and within 7 days of the start of treatment)

Platelets >= 100,000/L (unsupported) (within 14 days of registration and within 7 days of the start of treatment)

I haven't taken any growth factor medications for at least 1 or 2 weeks.

Exclusion Criteria

I have seizures that are not controlled by medication.

I have been treated with a BRAF inhibitor before, but not sorafenib.

I do not have any serious illnesses that could affect the study.

Treatment Details

Interventions

• Selumetinib (Kinase Inhibitor)

Trial Overview The trial is examining the effects and optimal dosage of Selumetinib, a drug intended to inhibit tumor growth by blocking enzymes necessary for cell proliferation. It's designed as a phase I/II study to determine side effects and effectiveness in children and young adults.

Participant Groups

Group I: Treatment (selumetinib) Experimental Treatment 2 Interventions

Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience a sustained objective response from selumetinib on the phase I or phase II portions of the trial, and who have completed 2 years of treatment and stopped study drug may be enrolled on the re-treatment study after progression/recurrence. Patients in the re-treatment study may continue treatment indefinitely in the absence of disease progression or unacceptable toxicities. Patients undergo blood sample collection on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School