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Sponsored by: |
University of Washington |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002687 |
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: aldesleukin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PHASE IB TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH STAGE III OR IV MYCOSIS FUNGOIDES |
Estimated Enrollment: | 30 |
Study Start Date: | February 1995 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses.
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD.
Patients are followed at least 3 times during year 1 and then annually thereafter.
PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically and histologically proven diagnosis of 1 of the following:
Mycosis fungoides (MF) meeting 1 of the following conditions:
Sezary syndrome
No clinically significant ascites or pleural effusion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
No significant CNS dysfunction, including any of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 |
Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
Study ID Numbers: | CDR0000064412, UW-24218-A/E, NCI-V95-0758 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002687 |
Health Authority: | United States: Federal Government |
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 II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Mycosis Fungoides Recurrence Mycoses |
Lymphatic Diseases Aldesleukin Interleukin-2 Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions |
Neoplasms Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |