Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal
RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill the tumor cells.
PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from white blood cells and melanoma cells in treating patients with metastatic melanoma who are undergoing surgery for lymph node and tumor removal.
|Melanoma (Skin)||Biological: aldesleukin Biological: gp100 antigen Biological: tyrosinase peptide||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase I-II Trial of Antigen-Pulsed Autologous Dendritic Cells for Induction of Anti-Tumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma|
|Study Start Date:||July 1997|
|Study Completion Date:||February 2005|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety and toxicity of intravenous injections of autologous cultured dendritic cells pulsed with either gp100 and tyrosinase peptides or autologous melanoma tumor cell lysates in patients with metastatic melanoma. II. Determine whether treatment with melanoma tumor antigen pulsed autologous dendritic cells results in increased in vitro tumor specific cytotoxic T-cell responses. III. Determine whether this treatment can induce positive skin test responses to tumor antigens. IV. Evaluate the disease free and overall survival of these patients.
OUTLINE: This is a randomized, dose escalation study. Approximately 1-2 weeks following surgical lymphadenectomy, patients undergo leukapheresis to collect dendritic cells and are then divided into 3 groups. Group A consists of patients without adequate tumor for preparation of tumor lysate and who have tumors that express tyrosinase or gp100 with types HLA-A1, A2, or A3. Group B consists of the patients who have adequate tumor for lysate preparation but who do not type for HLA-A1, A2, or A3 (required for the peptide pulsed protocol). Group C are the patients with adequate tumor who are eligible for the peptide pulsed protocol. Group A patients receive autologous dendritic cells pulsed with appropriate peptide antigens. Group B patients are treated with autologous dendritic cells pulsed with autologous tumor cell lysates. Group C patients are randomized to receive dendritic cells pulsed with either peptide antigens or tumor lysate. All patients are administered intravenous active immunotherapy for 4 monthly intervals. The dose of the immunizations is escalated for each cohort of three patients that is accrued in each of the groups mentioned above. Each immunization at each dose level is followed by three days of interleukin-2 administered subcutaneously twice daily. Patients are followed at least 5 years for survival.
PROJECTED ACCRUAL: There will be 100 patients accrued in this study over 2 years. There will be 50, 20, and 30 patients in groups A, B, and C, respectively.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003229
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Virginia|
|Cancer Center, University of Virginia HSC|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Hilliard F. Seigler, MD||Duke Cancer Institute|