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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: | NCT00005788 |
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.
PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.
Condition | Intervention | Phase |
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Lymphoma |
Biological: aldesleukin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 15-35 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:
Histologically proven mycosis fungoides or Sezary syndrome
Measurable disease with 1 or more indicator lesions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067726, NU-96H7, NCI-G00-1735 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005788 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 |
Anti-HIV Agents Immunoproliferative Disorders Sezary Syndrome Mycosis Fungoides Antiviral Agents Recurrence Lymphoma, Small Cleaved-cell, Diffuse Mycoses Lymphatic Diseases Aldesleukin Anti-Retroviral Agents |
Analgesics, Non-Narcotic Interleukin-2 Cutaneous T-cell Lymphoma Lymphoma, T-Cell Peripheral Nervous System Agents Analgesics Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Anti-Infective Agents Antineoplastic Agents Physiological Effects of Drugs Sezary Syndrome Mycosis Fungoides Mycoses Pathologic Processes Anti-Retroviral Agents Sensory System Agents Lymphoma, T-Cell Syndrome Therapeutic Uses Analgesics Lymphoma Anti-HIV Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Central Nervous System Agents |