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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004106 |
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 |
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Lymphoma |
Drug: temozolomide |
Phase II |
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.
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:
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 |
Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067325, NU-FDA97H3, NCI-G99-1597 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004106 History of Changes |
Health Authority: | United States: Federal Government |
stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
Immunoproliferative Disorders Sezary Syndrome Mycosis Fungoides Temozolomide Recurrence Lymphoma, Small Cleaved-cell, Diffuse Mycoses Lymphatic Diseases |
Cutaneous T-cell Lymphoma Lymphoma, T-Cell Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Lymphoma Lymphoma, T-Cell, Cutaneous |
Disease Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Sezary Syndrome Mycosis Fungoides Temozolomide Pharmacologic Actions Mycoses Lymphatic Diseases |
Neoplasms Pathologic Processes Therapeutic Uses Syndrome Lymphoma, T-Cell Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Lymphoma Lymphoma, T-Cell, Cutaneous |