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

Sponsor
Duke University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00046878
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme
Actual Study Completion Date :
Aug 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Duke University
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Henry S. Friedman, MD, Duke Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT00046878
    Other Study ID Numbers:
    • 3318
    • DUMC-3318-01-12
    • NCI-5632
    • CDR0000256332
    First Posted:
    Aug 11, 2003
    Last Update Posted:
    Mar 28, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Duke University
    adult glioblastoma
    adult giant cell glioblastoma
    adult gliosarcoma
    Additional relevant MeSH terms:
    Glioblastoma
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Carmustine
    O(6)-benzylguanine

    Study Results

    No Results Posted as of Mar 28, 2013