Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00046878

Enrollment

Registered

2003-08-11

Start date

Unknown

Completion date

2002-08-31

Last updated

2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

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. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining carmustine with O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Detailed description

OBJECTIVES: * Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then referred for radiotherapy. Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy. PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Interventions

DRUGO6-benzylguanine

DRUGcarmustine

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy * Measurable residual disease on a contrast-enhanced MRI or CT scan (for patients with a medical contraindication for MRI) with a baseline scan obtained at the corticosteroid dose the patient is receiving on the day of treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin greater than 10 g/dL Hepatic * Bilirubin normal * SGOT no greater than 2.5 times upper limit of normal Renal * Creatinine no greater than 1.5 mg/dL * BUN no greater than 25 mg/dL Pulmonary * DLCO greater than 75% predicted Other * 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 * Not specified Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics * Concurrent corticosteroids allowed if on stable dose for 3 days before study Radiotherapy * See Disease Characteristics Surgery * No more than 28 days since prior surgical resection or biopsy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026