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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004106 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or Sezary syndrome that has not responded to previous treatment.
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: temozolomide |
Phase II |
| MedlinePlus related topics: | Cancer Fungal Infections Lymphoma |
| ChemIDplus related topics: | Temozolomide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome |
| Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mycosis fungoides or Sezary syndrome
Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only
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, Connecticut | |||||
| Yale Comprehensive Cancer Center at Yale University School of Medicine | |||||
| New Haven, Connecticut, United States, 06520-8028 | |||||
| United States, Illinois | |||||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |||||
| Chicago, Illinois, United States, 60611-3013 | |||||
| University of Chicago Cancer Research Center | |||||
| Chicago, Illinois, United States, 60637-1470 | |||||
| Robert H. Lurie Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067325, NU-FDA97H3, NCI-G99-1597 |
| First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004106 |
| Health Authority: | United States: Federal Government |
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