Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy.

• - Anaplastic astrocytoma.

• - Anaplastic oligodendroglioma.

• - Glioblastoma multiforme.

• - Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy.

• - Measurable disease by serial MRI or CT scan.

PATIENT CHARACTERISTICS: Age:

• - 18 and over.

Performance status:

• - Karnofsky 60-100% Life expectancy: - Not specified.

Hematopoietic:

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

• - Hemoglobin at least 10 g/dL.

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

Hepatic:

• - Bilirubin no greater than 2.0 mg/dL.

• - Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) - SGOT and SGPT no greater than 3 times ULN.

Renal:

• - Creatinine no greater than 2.0 mg/dL.

Pulmonary:

• - Resting oxygen saturation on room air at least 90% by pulse oximetry.

• - FVC, DLCO, and FEV_1 at least 50% of normal.

Other:

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception.

• - No other serious concurrent medical illness that would preclude study compliance.

• - No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - At least 3 weeks since prior investigational biologics.

Chemotherapy:

• - See Disease Characteristics.

• - No prior nitrosoureas for glioma.

• - No more than 1 prior chemotherapy regimen.

• - At least 4 weeks since prior chemotherapy.

• - No prior efaproxiral.

Endocrine therapy:

• - Concurrent corticosteroids (e.g., dexamethasone) allowed.

Radiotherapy:

• - See Disease Characteristics.

• - At least 90 days since prior radiotherapy.

Surgery:

• - Not specified.

Other: - At least 3 weeks since other prior investigational drugs or devices

OBJECTIVES:

• - Evaluate the safety and tolerability of escalating doses of efaproxiral (RSR13) when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma.

• - Determine the maximum tolerated dose (MTD) of RSR13 when administered with carmustine in this patient population.

• - Determine the pharmacokinetic profile of this regimen in these patients.

• - Estimate the efficacy of this regimen at the MTD in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of efaproxiral (RSR13). Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose. Patients are followed at 6 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this study. A maximum of 47 patients will be accrued for the phase II portion of this study.