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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Chiron Corporation |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00338377 |
Purpose
The goal of this clinical research study is to learn if a vaccine prepared from special blood cells (dendritic cells) will improve the function of fighting immune cells (T cells) specific for melanoma. These special blood cells and immune cells will be taken from patient's blood and tissue and grown in the laboratory and then given back to the patient. Researchers will also study the ability of these cells to shrink or slow the growth of the metastatic melanoma when given with chemotherapy and Interleukin-2 (IL-2).
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: Dendritic Cell Immunization Drug: Cyclophosphamide Drug: Fludarabine Biological: T Cells Biological: Interleukin-2 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma |
| Estimated Enrollment: | 98 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Chemotherapy + IL-2 plus T-cells |
Drug: Cyclophosphamide
60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion
Other Names:
Drug: Fludarabine
25 mg/m^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
Other Names:
Biological: T Cells
On Days 0, up to 1.5 x 10^11 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.
Other Names:
|
|
Experimental: Chemotherapy + IL-2 plus T-Cells + Vaccine
Chemotherapy and IL-2 plus T-cells and the vaccine of dendritic cells
|
Biological: Dendritic Cell Immunization
1x10^7 to 2.5x10^8 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
Other Names:
Drug: Fludarabine
25 mg/m^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
Other Names:
Biological: T Cells
On Days 0, up to 1.5 x 10^11 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.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00338377 History of Changes |
| Other Study ID Numbers: | 2004-0069 |
| Study First Received: | February 10, 2006 |
| Last Updated: | November 16, 2011 |
| 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 |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Cyclophosphamide Fludarabine monophosphate Fludarabine Aldesleukin Interleukin-2 Vidarabine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |