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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00005081
First received: April 6, 2000
Last updated: August 20, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: O6-benzylguanine
Drug: carmustine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent or Progressive Cerebral Anaplastic Gliomas

Resource links provided by NLM:


Further study details as provided by Duke University:

Study Start Date: August 2000
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005081

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00005081     History of Changes
Other Study ID Numbers: 0059, DUMC-0059-00-1, DUMC-T98-0059, NCI-T98-0059, CDR0000067688
Study First Received: April 6, 2000
Last Updated: August 20, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Carmustine
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014