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Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00003467
Collaborator
National Cancer Institute (NCI) (NIH)
68
Enrollment
1
Location
73
Duration (Months)
0.9
Patients Per Site Per Month

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.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

Condition or Disease Intervention/Treatment Phase
  • Drug: carmustine
  • Drug: polifeprosan 20 with carmustine implant
  • Procedure: surgical procedure
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.

  • Assess the toxicity of this therapy in these patients.

OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).

Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Primary Purpose:
Treatment
Official Title:
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Study Start Date :
Jan 1, 1998
Actual Study Completion Date :
Feb 1, 2004

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 recurrent primary low grade glioma including:

    • Fibrillary astrocytoma

    • Oligodendroglioma

    • Mixed glioma

    • Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Karnofsky 60-100%
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Hematocrit greater than 29%

    • Absolute neutrophil count greater than 1500/mm^3

    • Platelet count greater than 125,000/mm^3

    Hepatic:

    • SGOT less than 1.5 times upper limit of normal (ULN)

    • Bilirubin less than 1.5 times ULN

    Renal:

    • Creatinine less than 1.5 mg/dL

    • BUN less than 25 mg/dL

    Other:

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • At least 4 weeks since prior chemotherapy unless disease progression
    Endocrine therapy:

    • Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)

    • No concurrent immunosuppressive agents

    Radiotherapy:
    • At least 4 weeks since prior radiotherapy unless disease progression
    Surgery:
    • Not specified
    Other:
    • No other concurrent medication that may interfere with study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke Comprehensive Cancer Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Henry S. Friedman, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003467
    Other Study ID Numbers:
    • 1706
    • DUMC-1706-02-9R5
    • DUMC-1706-01-9R4
    • DUMC-000693-00-4
    • DUMC-1509-97-10
    • DUMC-1568-98-10R1
    • DUMC-1706-00-9R3
    • DUMC-97131
    • NCI-G98-1470
    • CDR0000066503
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 20, 2013
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    recurrent adult brain tumor
    adult brain stem glioma
    adult mixed glioma
    adult anaplastic astrocytoma
    adult pilocytic astrocytoma
    adult oligodendroglioma
    Additional relevant MeSH terms:
    Glioma
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Carmustine

    Study Results

    No Results Posted as of Jun 20, 2013