Brain and Central Nervous System Tumors
Conditions
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
Detailed description
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.)
Interventions
PROCEDUREconventional surgery
Sponsors
Direct Therapeutics
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed