Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent or Progressive Cerebral Anaplastic Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005081
• Other study ID #: 0059
• Secondary ID: DUMC-0059-00-1DU
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: August 20, 2014
• Start date: August 2000
• Est. completion date: April 2001

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma.

Description:

OBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma Resistant to nitrosourea (defined as progressive or recurrent disease within 8 weeks of receiving nitrosourea) Measurable residual disease by MRI or CT scan

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 80% predicted Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosourea, procarbazine, or mitomycin and recovered No prior nitrosourea greater than 1,200 mg/m2 Endocrine therapy: Concurrent stable dose corticosteroids allowed if on for at least two weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• O6-benzylguanine

• carmustine

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,