Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
Phase 1
Completed
- Conditions
- Melanoma (Skin)
- Interventions
- Biological: dendritic cell-MART-1 peptide vaccine
- Registration Number
- NCT00039325
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm E - A*0201-/DR*04+ - phase 2 dendritic cell-MART-1 peptide vaccine Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations. Arm B - dose increase for phase 1 dendritic cell-MART-1 peptide vaccine A\*0201 positive subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations. Arm D - A*0201+/DR*04- - phase 2 dendritic cell-MART-1 peptide vaccine Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations. Group A - first dose for phase 1 dendritic cell-MART-1 peptide vaccine A\*0201 positive subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^6. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations. Arm C - A*0201+/DR*04+ subjects - Phase II dendritic cell-MART-1 peptide vaccine Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
- Primary Outcome Measures
Name Time Method Optimal dose 7 months
- Secondary Outcome Measures
Name Time Method Immunological response (peptide-specific T cell generation, skin test immunohistology) 7 months Clinical response (disease improvement or disease progression) 7 months Safety of administering MART-1 adenovirus transduced dendritic cells 7 months
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States