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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005954 |
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 | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Treatment of Adults With Brain Metastases With Temodar |
Study Start Date: | August 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic lesions to the brain
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Henry S. Friedman, MD | Duke University |
Study ID Numbers: | CDR0000067934, DUMC-2114-02-12R3, NCI-G00-1798 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005954 |
Health Authority: | United States: Federal Government |
adult tumors metastatic to brain |
Neoplasm Metastasis Central Nervous System Neoplasms Temozolomide Nervous System Neoplasms |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Nervous System Diseases Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |