Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically proven supratentorial malignant glioblastoma multiforme.

• - Clear evidence of disease progression by MRI.

• - Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated) - Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm.

• - No brainstem (pons or medulla) or midbrain (mesencephalon) involvement.

• - No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve.

• - No tumor extension into the ventricular system.

• - Tumor volume no greater than 33.4 cm3.

• - At least one prior radiotherapy.

PATIENT CHARACTERISTICS: Age:

• - 18 to 75.

Performance status:

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

Hematopoietic:

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

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

• - No evidence of bleeding diathesis.

Hepatic:

• - Bilirubin no greater than 2.0 mg/dL.

• - SGOT/SGPT no greater than 2.5 times normal.

Renal:

• - Creatinine no greater than 2.0 mg/dL OR.

• - Creatinine clearance at least 40 mL/min.

• - BUN no greater than 30 mg/dL.

Other:

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception.

• - No active uncontrolled infection.

• - Afebrile unless fever due to presence of tumor.

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

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - Not specified.

Chemotherapy:

• - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered.

Endocrine therapy:

• - Not specified.

Radiotherapy:

• - See Disease Characteristics.

• - At least 4 weeks since prior radiotherapy and recovered.

• - No prior intracranial brachytherapy.

Surgery:

• - Recovered from any prior surgery.

Other:

• - No prior anticoagulants.

- No other concurrent investigational agents

OBJECTIVES:

• - Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme.

(Phase I of this study closed to accrual as of 01/15/2002.)

• - Determine the qualitative and quantitative toxicity of this regimen in these patients.

• - Assess the activity of this regimen in these patients.

• - Estimate peripheral blood carmustine levels in these patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy. Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.) Additional patients then receive treatment with DTI-015 at the recommended phase II dose. Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression. PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)