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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00537069 |
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, before a donor lymphocyte infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's lymphocytes. Giving an infusion of donor lymphocytes that have been treated in the laboratory after chemotherapy may help destroy any remaining tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving chemotherapy followed by laboratory-treated donor lymphocytes and high-dose aldesleukin may be an effective treatment for metastatic melanoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of laboratory-treated donor lymphocytes when given together with cyclophosphamide, fludarabine, and high-dose aldesleukin and to see how well they work in treating patients with metastatic melanoma that did not respond to previous treatment.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: aldesleukin Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Phase I/II Study Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Allogeneic Tumor-Reactive Lymphocyte Cell Line DMF5 in Metastatic Melanoma |
Estimated Enrollment: | 30 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I dose-escalation study of allogeneic DMF5 cells followed by an open-label phase II study.
Phase I:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of melanoma, meeting both of the following criteria:
PATIENT CHARACTERISTICS:
No other major medical illness of the cardiovascular, respiratory, or immune system as evidenced by any of the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior systemic therapy and recovered
More than 6 weeks since prior ipilimumab (MDX-010)
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Responsible Party: | NCI - Surgery Branch ( Steven A. Rosenberg ) |
Study ID Numbers: | CDR0000565964, NCI-07-C-0210 |
Study First Received: | September 27, 2007 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00537069 History of Changes |
Health Authority: | Unspecified |
recurrent melanoma stage IV melanoma |
Antimetabolites Anti-HIV Agents Immunologic Factors Cyclophosphamide Fludarabine monophosphate 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 Fludarabine Antirheumatic Agents Alkylating Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Melanoma Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Alkylating Agents |
Anti-HIV Agents Neoplasms by Histologic Type Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Antirheumatic Agents |