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| Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052377 |
Purpose
RATIONALE: Biological therapies, such as interleukin-12 and interleukin-2, use different ways to stimulate the immune system and stop cancer cells from growing. Combining more than one biological therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: aldesleukin Biological: recombinant interleukin-12 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Open-Label Study Of Recombinant Human Interleukin-12 (NSC 672423) In Mycosis Fungoides (MF) Patients With Cross-Over To Phase I Evaluation Of Escalating Doses Of Interleukin-2 (NSC 373364) Administered With Interleukin-12 |
| Study Start Date: | October 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter, dose-escalation study of interleukin-2 (IL-2).
Patients receive interleukin-12 (IL-12) subcutaneously (SC) twice weekly for 24 weeks.
Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24.
Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks.
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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended dose (RD) is the dose preceding the MTD. Additional patients are treated at the RD.
Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 28 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mycosis fungoides
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 8 weeks since prior treatment with any single chemotherapeutic agent (12 weeks for multiple chemotherapeutic agents)
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| United States, Massachusetts | |
| Cancer Center at Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Pennsylvania | |
| Abramson Cancer Center at the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| MD Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53715 | |
| Study Chair: | Alain H. Rook, MD | University of Pennsylvania |
More Information
| Study ID Numbers: | CDR0000258239, UPCC-10401, NCI-1831 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052377 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent mycosis fungoides/Sezary syndrome 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 cutaneous T-cell non-Hodgkin lymphoma 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 |
|
Interleukin-12 Immunologic Factors Sezary Syndrome Mycosis Fungoides Lymphoma, Small Cleaved-cell, Diffuse Mycoses Anti-Retroviral Agents Cutaneous T-cell Lymphoma Lymphoma, T-Cell Analgesics Lymphoma Immunoproliferative Disorders Anti-HIV Agents |
Adjuvants, Immunologic Angiogenesis Inhibitors Antiviral Agents Recurrence Lymphatic Diseases Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous |
|
Anti-Infective Agents Interleukin-12 Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Sezary Syndrome Mycosis Fungoides Mycoses Anti-Retroviral Agents Sensory System Agents Lymphoma, T-Cell Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Analgesics |
Lymphoma Anti-HIV Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Growth Substances Adjuvants, Immunologic Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Lymphatic Diseases Neoplasms Aldesleukin Interleukin-2 Analgesics, Non-Narcotic |