Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with temozolomide in treating patients with malignant glioma.

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

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Imatinib Mesylate; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma

• Any of the following subtypes:

• Glioblastoma multiforme

• Gliosarcoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic oligoastrocytoma

• Previous histologic diagnosis of a lower grade of glioma allowed if there is histologic evidence of progression to a diagnosis of malignant glioma

• Multifocal disease allowed

• Must have undergone prior conventional external-beam radiation therapy

• Stable disease, disease recurrence, or relapsed disease

• Must not have received any systemic therapy for this recurrence or relapse

• No prior progressive disease

• No central/systemic fluid collections (pericardial effusion, pulmonary effusion, ascites) ≥ grade 2

• No evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative grade 1 hemorrhage

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Absolute neutrophil count > 1,500/mm³

• Hemoglobin > 9 g/dL

• Platelet count > 100,000/mm³

• AST and ALT < 2.5 times upper limit of normal (ULN)

• Bilirubin < 1.5 times ULN

• Creatinine < 1.5 times ULN

• No chronic renal disease

• No active uncontrolled infection

• No uncontrolled diabetes

• No excessive risk of bleeding, as defined by occurrence of any of the following:

• Stroke within the past 6 months

• History of CNS or intraocular bleed

• Septic endocarditis

• No history of labile hypertension

• No congestive heart failure

• No poorly controlled hypertension

• No myocardial infarction within the past 6 months

• No history of poor compliance with antihypertensive regimen

• No other severe and/or uncontrolled medical disease that would preclude study participation

• No peripheral edema ≥ grade 2

• No gastrointestinal bleeding

• No gross hematuria

• No other active systemic bleeding

• Patients must not have experienced toxicity ≥ grade 3 with prior treatment with either temozolomide or imatinib mesylate

• No other primary malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix or other cancer not currently clinically significant nor requiring active interventions

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from all prior therapy

• Prior surgical resection(s) allowed

• At least 2 weeks since prior surgery

• At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• At least 2 weeks since prior external-beam radiotherapy

• At least 2 weeks since prior investigational drugs

• More than 1 week since prior biologic, immunotherapeutic, or cytostatic agents

• No concurrent warfarin