Study on Selumetinib for Treating Young Patients with Recurrent or Hard-to-Treat Low Grade Glioma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01089101
This clinical trial is testing the safety and effectiveness of the drug selumetinib in young patients with low grade glioma that has returned or is not responding to treatment. Selumetinib may help stop tumor growth by blocking certain enzymes needed for cell growth.
Patient Parameters
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Program Overview
This study aims to find the best dose of selumetinib and understand its side effects in young patients with low grade glioma that has come back or is not responding to treatment. Selumetinib works by blocking enzymes that help tumor cells grow. The trial will also look at how well the drug works in shrinking tumors and keeping the disease stable over time.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of selumetinib for children with recurrent or hard-to-treat low grade glioma. They will also study the side effects and how the drug is processed in the body. In Phase II, the focus will be on how well selumetinib works in controlling the disease.
Patients will take selumetinib orally twice a day in 28-day cycles, for up to 26 cycles, unless the disease progresses or side effects become unacceptable. If patients respond well to the treatment and complete two years of therapy, they may be eligible for re-treatment if the disease returns.
The study will also explore how different genetic factors affect the drug's effectiveness and safety. Researchers will collect blood samples and use imaging tests to monitor the tumors before and after treatment.
After finishing the treatment, patients will be followed up for 30 days to check for any lasting effects.
Eligibility Criteria
Inclusion Criteria
- Must have imaging tests done within three weeks before joining the study.
- Must start treatment within seven days of joining the study.
- Must provide a tumor sample for BRAF testing.
- Must be between 3 and 21 years old.
- Must have a specific type of low grade glioma, with or without certain genetic markers.
- Must have measurable disease that can be tracked with imaging tests.
- Must have tried other treatments before, except surgery, and recovered from any side effects.
- Must meet specific blood count and organ function requirements.
- Must be able to swallow capsules.
- Must agree to use birth control if of childbearing potential.
- Must be willing to sign informed consent.
- For re-treatment, must have disease progression after previous selumetinib treatment and meet similar criteria as initial treatment.
Exclusion Criteria
- Cannot have serious unrelated illnesses that could interfere with the study.
- Cannot be on other cancer treatments or investigational drugs.
- Cannot have uncontrolled seizures.
- Cannot have used certain other cancer drugs before.
- Cannot have heart conditions that increase the risk of heart rhythm problems.
- Cannot have allergies to similar drugs as selumetinib.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Lucile Packard Children's Hospital Stanford University | 94304 | Palo Alto | California |
| UCSF Medical Center-Mount Zion | 94115 | San Francisco | California |
| UCSF Medical Center-Parnassus | 94143 | San Francisco | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Children's National Medical Center | 20010 | Washington D.C. | District of Columbia |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | 30329 | Atlanta | Georgia |
| Lurie Children's Hospital-Chicago | 60611 | Chicago | Illinois |
| Children's Memorial Outpatient Center in Lincoln Park | 60614 | Chicago | Illinois |
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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