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| Sponsor: | Norris Cotton Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005812 |
Purpose
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 |
|
Neoplasms Neoplastic Processes Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents Temozolomide Pharmacologic Actions |