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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00438984 |
Purpose
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 and aldesleukin may be an effective treatment for metastatic melanoma.
PURPOSE: This phase I trial is studying the side effects of cyclophosphamide, cellular adoptive immunotherapy, and aldesleukin in treating patients with metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: aldesleukin Biological: therapeutic autologous lymphocytes Drug: cyclophosphamide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma |
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized study. Patients undergo leukapheresis or blood draws for collection of peripheral blood mononuclear cells for the generation of antigen-specific cytotoxic T-lymphocyte (CTL) clones. Patients are assigned to 1 of 2 treatment cohorts.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
No current CNS metastases
PATIENT CHARACTERISTICS:
Must meet the following criteria to undergo leukapheresis:
No clinically significant pulmonary dysfunction, including any of the following:
No significant cardiovascular abnormalities, including any of the following:
Normal cardiac stress within the past 182 days required for patients with any of the following:
PRIOR CONCURRENT THERAPY:
No other concurrent immunotherapy, including any of the following:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| Principal Investigator: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000531135, FHCRC-2140.00 |
| Study First Received: | February 20, 2007 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00438984 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent melanoma stage IV melanoma |
|
Anti-HIV Agents Immunologic Factors Cyclophosphamide Antiviral Agents Immunosuppressive Agents Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Aldesleukin Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Antirheumatic Agents Alkylating Agents |
|
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Cyclophosphamide Melanoma Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Alkylating Agents |
Neoplasms by Histologic Type Anti-HIV Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |