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Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00003464
Collaborator
National Cancer Institute (NCI) (NIH)
50
Enrollment
1
Location
71
Duration (Months)
0.7
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 temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.

  • Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.

  • Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.

OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: This study will accrue 50 patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Primary Purpose:
Treatment
Official Title:
Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
Study Start Date :
Sep 1, 1997
Actual Study Completion Date :
Aug 1, 2003

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 proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy

    • At least 1 bidimensionally measurable lesion

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Karnofsky 70-100%
    Life expectancy:
    • Greater than 12 weeks
    Hematopoietic:

    • Absolute neutrophil count at least 1500/mm^3

    • Platelet count at least 100,000/mm^3

    • Hemoglobin at least 10 g/dL

    Hepatic:

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

    • SGOT and SGPT less than 2.5 times ULN

    • Alkaline phosphatase less than 2 times ULN

    Renal:

    • BUN less than 1.5 times ULN

    • Creatinine less than 1.5 times ULN

    Other:

    • Must be neurologically stable

    • No systemic disease

    • No acute infection requiring intravenous antibiotics

    • No frequent vomiting

    • No other medical condition that would interfere with oral medication intake such as partial bowel obstruction

    • No prior or concurrent malignancies except:

    • Surgically cured carcinoma in situ of the cervix

    • Basal or squamous cell carcinoma of the skin

    • HIV negative

    • No AIDS-related illness

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No prior biologic therapy

    • No concurrent biologic therapy (growth factors or erythropoietin)

    Chemotherapy:

    • No prior chemotherapy

    • No other concurrent chemotherapy

    Endocrine therapy:
    • Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study)
    Radiotherapy:

    • No prior radiation therapy

    • No prior interstitial brachytherapy

    • No prior radiosurgery to the brain

    • Not requiring immediate radiation therapy

    • No concurrent radiotherapy

    Surgery:

    • Recovered from any effects of prior surgery

    • At least 2 weeks since prior surgical resection

    Other:
    • No other concurrent investigational drugs

    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:
    NCT00003464
    Other Study ID Numbers:
    • 1171
    • DUMC-1171-01-6R4
    • DUMC-1016-97-7
    • DUMC-1056-98-7R1
    • DUMC-1058-98-7R1
    • DUMC-1171-00-6R3
    • DUMC-1231-99-7R2
    • DUMC-97081
    • NCI-G98-1465
    • CDR0000066498
    First Posted:
    Aug 20, 2003
    Last Update Posted:
    Jun 20, 2013
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    adult glioblastoma
    adult giant cell glioblastoma
    adult gliosarcoma
    Additional relevant MeSH terms:
    Glioblastoma
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Temozolomide

    Study Results

    No Results Posted as of Jun 20, 2013