This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments carmustine in ethanol, conventional surgery
Phase phase 2
Sponsor Direct Therapeutics
Start date June 2000
Trial identifier NCT00006656, CDR0000068207, DTI-9901, NCI-V00-1623, UCMC-00042402


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
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.)
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).