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

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

Criteria

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 to primary tumor

• At least 2 weeks since prior focal radiotherapy for symptomatic

• At least 3 months since prior bone marrow transplantation

• Neurological deficits allowed if stable for at least 1 week prior to study

Exclusion Criteria

• Receiving other anticancer or experimental drug therapy.

• Ongoing uncontrolled infection.

• Significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or psychiatric disease.

• Deep venous or arterial thrombosis within 6 weeks of registration.

• Taking warfarin.

• Newly diagnosed diffuse intrinsic brainstem malignant glioma with disseminated disease (stratum I)

• Intratumoral hemorrhage