Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma (NCT01089101) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
United States217 participantsStarted 2010-07-07
Plain-language summary
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.
Who can participate
Age range
3 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration
* All other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration
* Patients must start therapy within 7 calendar days of registration
* Laboratory values must be no older than seven (7) days prior to the start of therapy; if a test that is repeated after registration and prior to therapy is outside the limits for eligibility, it must be rechecked within 48 hours prior to the start of therapy; if laboratory values still fail to meet eligibility criteria, the patient may not receive protocol therapy
* All patients must meet the following inclusion and exclusion criteria; NO EXCEPTIONS WILL BE GIVEN
* Participant is willing to sign a screening consent and provide adequate pre-trial tumor material for BRAF testing (both for BRAF V\^600E mutation and BRAF KIAA1549 fusion assessments)
* All patients who are candidates for enrollment in stratum 5 based on their tumor histology must be pre-screened
* Screening may be applied to potential stratum 1 and 2 patients
* Patients whose prior BRAF testing was performed at another lab (Clinical Laboratory Improvement Amendments \[CLIA\]/College of American Pathologist \[CAP\] certified or otherwise) must send additional tumor material to Brigham and Women's Hospital (BWH) for confirmation; however, to preserve available tum…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in Phase 1/2 and is still working to establish the recommended dose of selumetinib, what does that mean for what's currently known about its safety profile in children, and how does that uncertainty compare to whatever standard treatment options remain for my child?
2My child's tumor may fall into one of several subtypes being studied here — like a visual pathway glioma or one related to Neurofibromatosis Type 1 — does their specific diagnosis match one of the stratum groups in this trial, and does that affect their eligibility or the evidence available for that subgroup?
3The trial is 'active but not recruiting,' which I think means it's no longer enrolling new patients — is that the case, and if so, are there other trials studying selumetinib or similar MEK inhibitors that my child might still be able to join?
4The Phase 2 part measures whether the tumor responds for at least 8 weeks — given where my child is in their treatment journey, is that kind of response window a meaningful goal for their situation, or would a different approach be more appropriate right now?
5I noticed the trial also includes a re-treatment study measuring disease stabilization — if my child had previously received selumetinib and their disease progressed again, is re-treatment something worth discussing, and what would the risks look like at that point?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose and recommended phase 2 dose of selumetinib determined by dose-limiting toxicities (phase I)