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Temozolomide in Treating Patients With Brain Metastases

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00005954
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
34
Duration (Months)

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 patients who have brain metastases.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the activity of temozolomide in patients with brain metastases.

  • Determine the toxicity of this treatment in these patients.

OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).

Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Treatment of Adults With Brain Metastases With Temodar
Study Start Date :
Aug 1, 2000
Actual Study Completion Date :
Jun 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:

    • Metastatic lesions to the brain

    • Must not require immediate radiotherapy

    • If received prior radiotherapy, must have progressive disease

    • Evaluable disease by CT scan or MRI

    • Neurologically stable

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

    • Absolute neutrophil count at least 1,500/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 or SGPT less than 2.5 times ULN

    • Alkaline phosphatase less than 2 times ULN

    Renal:

    • Blood urea nitrogen less than 1.5 times ULN

    • Creatinine less than 1.5 times ULN

    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No other concurrent nonmalignant systemic disease

    • No acute infection requiring treatment with IV antibiotics

    • HIV negative

    • No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow)

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No concurrent hematopoietic growth factors, including epoetin alfa

    • No other concurrent biologic therapy

    Chemotherapy:

    • At least 4 weeks since prior chemotherapy, unless evidence of disease progression

    • No other concurrent chemotherapy

    Endocrine therapy:
    • Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study
    Radiotherapy:

    • See Disease Characteristics

    • At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression

    • No concurrent radiotherapy

    Surgery:
    • At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered
    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:
    NCT00005954
    Other Study ID Numbers:
    • 2114
    • DUMC-2114-02-12R3
    • NCI-G00-1798
    • CDR0000067934
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 20, 2013
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    adult tumors metastatic to brain
    Additional relevant MeSH terms:
    Brain Neoplasms
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Temozolomide

    Study Results

    No Results Posted as of Jun 20, 2013