Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - One of the following: - Histologically confirmed high-grade glioma.

• - Glioblastoma multiforme.

• - Gliosarcoma.

• - Anaplastic astrocytoma.

• - Anaplastic oligodendroglioma.

• - Anaplastic mixed oligoastrocytoma.

• - Malignant glioma/astrocytoma, not otherwise specified.

• - Meningioma.

• - Hemangioblastoma.

• - Ependymoma.

• - Primitive neuroectodermal tumors.

• - Hemangiopericytoma.

• - Progressive glioma.

• - Clinically and radiographically diagnosed brain stem glioma.

• - Progressive or recurrent disease as determined by CT scan or MRI.

• - Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor.

• - Must have failed prior radiotherapy.

PATIENT CHARACTERISTICS: Age:

• - 18 and over.

Performance status:

• - Karnofsky 60-100% Life expectancy: - More than 8 weeks.

Hematopoietic:

• - WBC at least 2,300/mm^3.

• - Platelet count at least 90,000/mm^3.

• - Hemoglobin at least 8 g/dL (transfusions allowed) Hepatic: - Bilirubin less than 3 times upper limit of normal (ULN) - SGOT less than 3 times ULN.

• - No significant active hepatic disease.

Renal:

• - Creatinine less than 2.0 mg/dL OR.

• - Creatinine clearance at least 60 mL/min.

• - No significant active renal disease.

Cardiovascular:

• - No significant active cardiac disease.

Other:

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

• - No significant active psychiatric disease.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception during and for 2 months after study.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - At least 2 weeks since prior interferon.

• - No concurrent immunotherapy.

Chemotherapy:

• - At least 6 weeks since prior nitrosoureas.

• - At least 4 weeks since prior temozolomide or carboplatin.

• - At least 3 weeks since prior procarbazine.

• - At least 2 weeks since prior vincristine.

• - At least 4 weeks since other prior cytotoxic chemotherapy.

• - No concurrent chemotherapy.

Endocrine therapy:

• - At least 2 weeks since prior tamoxifen.

• - Concurrent steroids allowed for control of the signs and symptoms of increased intracranial pressure if on a stable dose for at least the past 5 days.

Radiotherapy:

• - See Disease Characteristics.

• - At least 2 weeks since prior radiotherapy.

• - No concurrent radiotherapy.

Surgery:

• - See Disease Characteristics.

• - At least 2 weeks since prior tumor resection.

Other:

• - At least 2 weeks since other prior noncytotoxic agents.

• - Concurrent enzyme-inducing antiepileptic drugs allowed.

• - No concurrent rifampin.

• - No concurrent grapefruit juice.

- No other concurrent investigational agents

OBJECTIVES:

• - Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas.

• - Determine the toxic effects of this drug in these patients.

• - Determine the pharmacokinetics of this drug in these patients.

• - Determine the antiangiogenic activity of this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs.#46;no). Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.