Clinical trial NCT00046878: Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Official title: Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke Cancer Institute
name: Henry S. Friedman, MD
role: STUDY_CHAIR
References: