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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058279 |
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining monoclonal antibody therapy with interleukin-2 may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy with interleukin-2 in treating patients who have metastatic melanoma.
Condition | Intervention | Phase |
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Intraocular Melanoma Melanoma (Skin) |
Drug: aldesleukin Drug: ipilimumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | MDX-CTLA4 Combined With IL-2 for Patients With Metastatic Melanoma |
Study Start Date: | February 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4).
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Phase I is closed to accrual as of 4/13/2004).
Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-51 patients (3-18 for phase I and 19-33 for phase II) will be accrued for this study within 1 year. (Phase I is closed to accrual as of 4/13/2004).
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV melanoma
Clinically evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000287211, NCI-03-C-0109 |
Study First Received: | April 7, 2003 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00058279 |
Health Authority: | United States: Federal Government |
stage IV melanoma extraocular extension melanoma recurrent melanoma iris melanoma |
ciliary body and choroid melanoma, medium/large size ciliary body and choroid melanoma, small size recurrent intraocular melanoma |
Eye Neoplasms Eye Diseases Cytotoxic T-lymphocyte antigen 4 Recurrence Melanoma Neuroendocrine Tumors Melanoma of the choroid Antibodies, Monoclonal Neuroectodermal Tumors Antibodies |
Uveal melanoma Aldesleukin Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Nevus Immunoglobulins |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Site Neoplasms by Histologic Type Anti-Retroviral Agents |
Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue Nevi and Melanomas Antiviral Agents Pharmacologic Actions |