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Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005812 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Metastatic Cancer |
Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.
Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.
Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.
PROJECTED ACCRUAL: A total of 14-24 patients 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:
Documented leptomeningeal metastases
Lymphomatous meningitis
Must meet 1 of the following criteria:
Untreated lymphomatous meningitis eligible if one of the following are true:
Leptomeningeal metastases diagnosed by at least 1 of the following:
Negative CSF cytology with compatible clinical syndrome plus MRI and/or CSF abnormalities
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New Hampshire | |
Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756-0002 |
Study Chair: | Thomas H. Davis, MD | Norris Cotton Cancer Center |
Study ID Numbers: | CDR0000067814, DMS-9812, NCI-G00-1782 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005812 History of Changes |
Health Authority: | United States: Federal Government |
leptomeningeal metastases |
Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents Temozolomide Lymphoma |
Neoplasms Neoplastic Processes Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents Temozolomide Pharmacologic Actions |