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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553306 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Giving cyclophosphamide together with cellular adoptive immunotherapy with or without aldesleukin may be an effective treatment for metastatic melanoma.
PURPOSE: This phase I/II trial is studying the side effects of cyclophosphamide, cellular adoptive immunotherapy, and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: aldesleukin Drug: cyclophosphamide Drug: therapeutic autologous lymphocytes Procedure: autologous hematopoietic stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Phase I/II Study To Evaluate The Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ and CD8+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma |
Estimated Enrollment: | 12 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo leukapheresis to provide peripheral blood mononuclear cells which will serve as a source of responder and stimulator cells for the in vitro generation of antigen-specific T cells over approximately 3-4 months. Patients may receive therapy during this time.
Patients receive an initial infusion of antigen-specific CD8+ cytotoxic T-lymphocyte clones over 30-60 minutes to provide a baseline for assessing the contribution of CD4+ helper T-cell clones to augmenting persistence and function of CD8+ T cells. The second infusion (given 3-4 weeks after the first) will consist of the same dose of CD8+ T cells as the first infusion, together with antigen-specific CD4+ T-cell clones. All infusions will be preceded by 48 hours with a single infusion of low-dose cyclophosphamide.
The first 6 patients will receive infusions without aldesleukin (IL-2). If no serious adverse toxicities are observed, then the next 6 patients will receive both first and second infusions with a 14-day course of low-dose IL-2 subcutaneously twice daily.
After completion of study therapy, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
None of the following is permitted prior to T-cell infusion:
Clinically significant pulmonary dysfunction, as determined by medical history and physical examination
Significant cardiovascular abnormalities, as defined by any of the following:
PRIOR CONCURRENT THERAPY:
No chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies < 3 weeks prior to T-cell therapy
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Cassian Yee ) |
Study ID Numbers: | CDR0000573262, FHCRC-2179.00 |
Study First Received: | November 2, 2007 |
Last Updated: | October 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00553306 |
Health Authority: | United States: Food and Drug Administration |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Aldesleukin Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Cyclophosphamide Nevus Recurrence Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |