CompletedPhase 1/2

Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma

United States62 participantsStarted 2005-03

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients 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.

DISEASE CHARACTERISTICS: * Diagnosis of high-grade glioma of 1 of the following types: * Unfavorable low-grade glioma * Gliomatosis cerebri or bithalamic involvement * Histologically confirmed high-grade glioma (WHO grade III or IV) of 1 of the following subtypes: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic oligoastrocytoma * Anaplastic ganglioglioma * Pleomorphic xanthoastrocytoma with anaplastic features * Malignant glioneuronal tumor * Glioblastoma multiforme * Gliosarcoma * Newly diagnosed disease * Intracranial or spinal cord tumors allowed PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Karnofsky 40-100% (age 17 to 21 years) OR * Lansky 40-100% (age 3 to 16 years) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * SGPT \< 5 times ULN * Albumin ≥ 2 g/dL Renal * Creatinine \< 2 times normal OR * Glomerular filtration rate \> 70 mL/min Cardiovascular * No significant cardiovascular problem Pulmonary * No significant pulmonary problem Other * Not pregnant or nursing * Fertile patients must use effective contraception * No uncontrolled infection * No significant medical illness PRIOR CONCURRENT THERAPY: Biologic therapy * No prior or concurrent biologic agents Chemotherapy …

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 With Dose-limiting Toxicity (DLT)

Timeframe: During the first 8 weeks of therapy

Maximum Tolerated Dose (MTD) of Erlotinib

Timeframe: During the first 8 weeks of therapy.

Progression Free Survival (PFS)

Timeframe: 1 and 2 years after end of therapy

Trial details

NCT IDNCT00124657

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

Results submitted2013-09-10

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