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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091104 |
RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine before a white blood cell infusion may suppress the immune system and allow tumor cells to be killed. Vaccines may make the body build an immune response to kill tumor cells. Aldesleukin may stimulate a person's white blood cells to kill tumor cells. Combining white blood cell infusion with vaccine therapy and aldesleukin may cause a stronger immune response and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gene-modified white blood cells when given together with cyclophosphamide, fludarabine, vaccine therapy, and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: MART-1:27-35 peptide vaccine Biological: aldesleukin Biological: filgrastim Biological: incomplete Freund's adjuvant Biological: therapeutic autologous lymphocytes Biological: therapeutic tumor infiltrating lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: autologous hematopoietic stem cell transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation Radiation: total-body irradiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Study in Metastatic Melanoma Using a Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 TCR-Gene Engineered Lymphocytes and Subsequent Peptide Immunization |
Estimated Enrollment: | 136 |
Study Start Date: | July 2004 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior immunization to melanoma antigens allowed
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NCI - Surgery Branch | |
Bethesda, Maryland, United States, 20892-1201 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000383246, NCI-04-C-0251, NCI-6974 |
Study First Received: | September 7, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00091104 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IV melanoma recurrent melanoma |
Antimetabolites Anti-HIV Agents Immunologic Factors Adjuvants, Immunologic 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 Freund's Adjuvant 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 Adjuvants, Immunologic Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Myeloablative Agonists Freund's Adjuvant Fludarabine Antineoplastic Agents, Alkylating |