Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas (NCT00042991) | Clinical Trial Compass
CompletedPhase 1/2
Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
United States69 participantsStarted 2002-07
Plain-language summary
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is studying how well giving gefitinib together with radiation therapy works in treating children with newly diagnosed glioma.
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:
* Tumor:
* Phase I: newly diagnosed non-disseminated diffuse intrinsic brainstem tumor or newly diagnosed (diagnostic scan must be within 4 weeks prior to treatment initiation), incompletely resected supratentorial malignant glioma (anaplastic astrocytoma, glioblastoma multiforme or other high-grade glioma) (STMG); the STMG group must have residual tumor evident on postoperative MRI or CT
* Phase II: only newly diagnosed non-disseminated diffuse intrinsic brain stem glioma patients are eligible
* Performance status: Karnofsky or Lansky \>= 50% assessed within two weeks prior to registration
* Prior/concurrent therapy:
* Chemotherapy: no prior therapy allowed, including prior gefitinib treatment
* Radiation therapy (XRT): no prior therapy allowed
* Bone marrow transplant: none prior
* Anti-convulsants: patients with brain stem glioma (BSG) receiving EIACD will not be eligible; patients with STMG will be eligible for this study even if they are receiving enzyme inducting anti-convulsant drugs (EIACD) and will be stratified by use of EIACDs
* Growth factors: off all colony forming growth factor(s) \> 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin)
* ANC \> 1,000/ul
* Platelets \> 100,000/ul (transfusion independent)
* Hemoglobin \> 8g/dl (may be transfused)
* Patients may have bone marrow involvement by disease
* Creatinine \< 2 x normal for age or GFR \> 70 ml/min/1.73m\^2
* Bilirubin \< 1.5 x normal institutional normal for ag…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy
Timeframe: Day 1 of gefitinib therapy to end of week 8
2
Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas
Timeframe: Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks
3
Median Survival in Newly Diagnosed Brain Stem Gliomas
Timeframe: Assessed from the start of therapy until three years after initiation of gefitinib therapy