TerminatedPhase 1/2

Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma

Stopped: Poor accrual

United States85 participantsStarted 2001-05

Plain-language summary

Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem glioma. Imatinib mesylate may interfere with the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining imatinib mesylate with radiation therapy may kill more tumor cells.

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 * Age 3 to 21 * Performance status of Karnofsky 50-100% OR Lansky 50-100% * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 (transfusion independent) * Hemoglobin greater than 8 g/dL (transfusion allowed) * Bilirubin no greater than 1.5 times normal for age * SGPT less than 3 times normal for age * Albumin at least 2 g/dL * Creatinine less than 1.5 times normal for age OR Glomerular filtration rate greater than 70 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 6 months after study participation * Stratum I * Newly diagnosed diffuse intrinsic brainstem malignant glioma * No disseminated disease * No radiographic evidence of intratumoral hemorrhage before or during radiotherapy * No prior chemotherapy (beyond routine corticosteroids) * No prior irradiation * Must not be receiving enzyme-inducing anticonvulsant drugs * Stratum II * Histologically confirmed recurrent or refractory anaplastic astrocytoma, glioblastoma multiforme, or other high-grade glioma (including recurrent brain stem glioma * No intratumoral hemorrhage unrelated to prior surgical procedure * No myelosuppressive chemotherapy within 3 weeks (6 weeks if a nitrosourea agent) of study entry * No prior imatinib mesylate * At least 3 months since prior craniospinal radiotherapy (18 Gy or more) * At least 8 weeks since prior local radiotherapy t…

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

Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy

Timeframe: Day 1 of Imatinib Mesylate Therapy to Week 8

Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy

Timeframe: Day 1 of Imatinib Mesylate Therapy to Week 8

Median Progression-free Survival (PFS)

Timeframe: Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks

Trial details

NCT IDNCT00021229

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2010-02-09

View on ClinicalTrials.gov More Brain and Central Nervous System Tumors trials

Plain-language summary

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.

What they're measuring

Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy

Timeframe: Day 1 of Imatinib Mesylate Therapy to Week 8

Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy

Timeframe: Day 1 of Imatinib Mesylate Therapy to Week 8

Median Progression-free Survival (PFS)

Timeframe: Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks