- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003792
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial
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.
Study Overview
Status
Conditions
Detailed Description
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
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75246
- Baylor University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAYUMC-098004
- CDR0000066935 (REGISTRY: PDQ (Physician Data Query))
- NCI-T98-0054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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