Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma

• Status: Completed
• Trial end date: 2006-08-15
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma.

PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.

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

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or unresectable malignant glioma

• Glioblastoma multiforme (phase I only)

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed oligoastrocytoma

• Malignant astrocytoma not otherwise specified

• Gliosarcoma

• Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR

• Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only)

• No prior intracranial hemorrhage

• Failed prior radiotherapy

• Progressive or recurrent disease by MRI or CT scan and/or resection

• PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery

• Stable dose of steroids for 5-7 days prior to MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)

• SGOT less than 2 times ULN

• No significant hepatic disease

Renal:

• Creatinine less than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No significant renal disease

Cardiovascular:

• No significant cardiac disease

• No deep venous or arterial thrombosis within the past 6 weeks

Pulmonary:

• No pulmonary embolism within the past 6 weeks

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for up to 6 months after study participation

• No other serious concurrent medical illness

• No serious active infection

• No concurrent disease that would obscure toxicity or alter drug metabolism

• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior interferon or thalidomide and recovered

• No concurrent immunotherapy

• No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

• Recovered from prior chemotherapy

• At least 4 weeks since prior cytotoxic therapy

• At least 2 weeks since prior vincristine

• At least 6 weeks since prior nitrosoureas

• At least 4 weeks since prior temozolomide

• At least 3 weeks since prior procarbazine

• Prior polifeprosan 20 with carmustine implant (Gliadel wafer) allowed

• Prior radiosensitizers allowed

• No other concurrent chemotherapy

• Phase I only:

• Prior chemotherapy required for anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic mixed oligoastrocytoma

• Prior treatment for up to 3 relapses allowed

• Phase II only:

• Prior chemotherapy not required

• Prior treatment for up to 2 relapses allowed

Endocrine therapy:

• See Disease Characteristics

• At least 1 week since prior tamoxifen and recovered

• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

• Recovered from prior surgical resection of recurrent or progressive disease

Other:

• At least 1 week since prior non-cytotoxic agents and recovered

• At least 1 week since prior tretinoin and recovered

• At least 2 weeks since prior drugs that affect hepatic metabolism

• No other concurrent investigational agents

• No concurrent warfarin