Vaccine Therapy in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00003792|
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : June 26, 2013
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RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: MART-1 antigen Biological: filgrastim Biological: flu matrix peptide p58-66 Biological: gp100 antigen Biological: recombinant MAGE-3.1 antigen Biological: tyrosinase peptide Procedure: in vitro-treated peripheral blood stem cell transplantation||Phase 1|
OBJECTIVES: I. Determine the safety and tolerability of antigen pulsed dendritic cell therapy in patients with metastatic melanoma. II. Perform serial analysis of T cell and B cell function in these patients after this treatment. III. Determine objective response and response duration in these patients after this treatment.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days 1-6, then undergo leukapheresis for 2-3 days, beginning on day 6. Mononuclear cells are selected for CD34+ cells in the laboratory, made into dendritic cells, and then pulsed with MART-1, gp100, tyrosinase, MAGE-3 peptides and flu matrix. These antigen pulsed dendritic cells (ApDCs) are used for vaccinations. Prior to vaccination, ApDCs are mixed with MART-1, gp100, tyrosinase, MAGE-3, and flu matrix. Patients receive this dendritic cell vaccine mixture SQ every 2 weeks for 4 priming doses. Patients receive 4 boost vaccinations SQ at 2 months, 5 months, 9 months, and 15 months following the last priming vaccination. Patients are followed monthly for 2 years.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial|
|Study Start Date :||April 1999|
|Actual Study Completion Date :||October 2006|
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
DISEASE CHARACTERISTICS: Histologically proven metastatic melanoma Measurable disease HLA-A2 01 phenotype No active CNS or hepatic metastases
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Normal CD4 and CD8 T cell numbers by flow cytometry Lactic dehydrogenase less than 2 times normal Hepatic: No viral hepatitis Renal: Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive heart failure Pulmonary: No prior asthma Immunologic: Positive intradermal skin test for mumps, histoplasmosis, or streptokinase antigen Immunoglobulin levels normal No prior autoimmune disease (lupus erythematosus, rheumatoid arthritis, or thyroiditis) No allergy to tetanus toxoid or influenza vaccine No sensitivity to E. coli drug preparations Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon At least 8 weeks since prior interleukin-2 Chemotherapy: No more than 3 prior courses of cytotoxic chemotherapy At least 8 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent immunosuppressive agents
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003792
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Study Chair:||Joseph W. Fay, MD||Baylor Health Care System|
|Other Study ID Numbers:||
CDR0000066935 ( Registry Identifier: PDQ (Physician Data Query) )
|First Posted:||July 16, 2004 Key Record Dates|
|Last Update Posted:||June 26, 2013|
|Last Verified:||October 2006|
stage IV melanoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs