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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Chiron Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00338377 |
The primary objective will be to determine whether patients receiving adoptively transferred, tumor antigen-specific T cells in combination with dendritic cells and high dose IL-2 have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone. Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells' anti-tumor activity and their ability to migrate to the tumor site. In addition, researchers will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo.
Condition | Intervention | Phase |
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Melanoma |
Biological: Dendritic Cell Immunization Drug: Cyclophosphamide Drug: Fludarabine Biological: T Cells Biological: Interleukin-2 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma |
Estimated Enrollment: | 83 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Chemotherapy + IL-2 plus T-cells: Experimental |
Drug: Cyclophosphamide
60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion
Drug: Fludarabine
25 mg/m^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
Biological: T Cells
On Days 0, 3x10^9 - 1x10^11 T cells by vein infusion over 30-60 minutes.
Biological: Interleukin-2
12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on D-1-5, as tolerated.
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Chemotherapy + IL-2 plus T-Cells + Vaccine: Experimental
Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells
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Biological: Dendritic Cell Immunization
1x10^7 to 1x10^8 MART-1 peptide-pulsed Dendritic Cells given by vein over 20-30 minutes approximately 4 hrs after receiving T cells.
Drug: Cyclophosphamide
60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion
Drug: Fludarabine
25 mg/m^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
Biological: T Cells
On Days 0, 3x10^9 - 1x10^11 T cells by vein infusion over 30-60 minutes.
Biological: Interleukin-2
12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on D-1-5, as tolerated.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
(Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria).
Exclusion Criteria:
Contact: Patrick Hwu, MD | 713-792-2921 | phwu@mdanderson.org |
Contact: Ralph Freedman, MD | 713-792-2933 | rfreedman@mdanerson.org |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Patrick Hwu, MD 713-792-2921 phwu@mdanderson.org | |
Principal Investigator: Patrick Hwu, MD |
Principal Investigator: | Patrick Hwu, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Patrick Hwu, MD/Professor ) |
Study ID Numbers: | 2004-0069 |
Study First Received: | February 10, 2006 |
Last Updated: | August 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00338377 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Melanoma Regional nodal disease Dendritic Cell Immunization Lymphodepletion Adoptive Cell Transfer T Cells Vaccine Cyclosphosphamide Cytoxan Neosar |
Dendritic Cells Tumor Infiltrating Lymphocytes TIL Cells MART Peptide Fludarabine Fludarabine Phosphate Fludara Proleukin IL-2 Interleukin-2 |
Antimetabolites Anti-Infective Agents Immunologic Factors Cyclophosphamide Melanoma Anti-Retroviral Agents Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Analgesics Alkylating Agents Anti-HIV Agents Fludarabine monophosphate |
Immunosuppressive Agents Antiviral Agents Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Fludarabine Nevus Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic 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 Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas |
Analgesics Alkylating Agents Anti-HIV Agents Neoplasms by Histologic Type Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Myeloablative Agonists |