Vaccine Therapy in Treating Patients With Advanced Melanoma
- Conditions
- Intraocular MelanomaMalignant Conjunctival NeoplasmMelanoma (Skin)
- Registration Number
- NCT00705640
- Lead Sponsor
- Craig L Slingluff, Jr
- Brief Summary
RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in treating patients with advanced melanoma.
- Detailed Description
OBJECTIVES:
* To assess the circulating CD8 T-cell response to vaccination with a multipeptide vaccine in patients with advanced melanoma.
* To determine whether immunization with peptides and incomplete Freund's adjuvant induces lymph-node-like aggregates (LNLA) and tertiary lymphoid organs (TLOs) in the skin of these patients.
* To determine whether extended immunization (vaccinations 4-6) is associated with induction of negative immune-regulatory processes in the vaccination site microenvironment/TLO.
* To characterize peptide-reactive CD4 and CD8 T cells in loco at sites of immunization with a multipeptide vaccine.
* To characterize the expression of toll-like receptors 4, 7, 8, and 9, and MyD88 in dendritic cells infiltrating vaccination sites over the course of 6 vaccinations and after vaccination.
OUTLINE: Patients are randomized to 1 of 10 arms.
All patients receive primary vaccine comprising melanoma multipeptides and tetanus toxoid helper peptide emulsified in incomplete Freund's adjuvant, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Vaccines are administered in a single skin location on an extremity clinically uninvolved with melanoma. A replicate vaccine site is identified for each patient for skin biopsy with or with out replica vaccine administration.
* Arm 1A: Patients receive no replicate vaccine. Patients undergo surgical biopsy at replicate vaccine site on day 1.
* Arm 1B: Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on day 1 and undergo surgical biopsy at replicate vaccine site on day 8 (1 week after replicate vaccine 1).
* Arm 1C: Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on days 1, 8, and 15 and undergo surgical biopsy at replicate vaccine site on day 22 (1 week after replicate vaccine 3).
* Arm 1D: Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 50 (1 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
* Arm 1E: Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 85 (6 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
* Arm 2A: Patients receive no replicate vaccine. Patients undergo surgical biopsy at replicate vaccine site on day 1.
* Arm 2B: Patients receive replicate vaccine (the same as primary vaccine) SC and ID on day 1 and undergo surgical biopsy at replicate vaccine site on day 8 (1 week after replicate vaccine 1).
* Arm 2C: Patients receive replicate vaccine (the same as primary vaccine) SC and ID on days 1, 8, and 15 and undergo surgical biopsy at replicate vaccine site on day 22 (1 week after replicate vaccine 3).
* Arm 2D: Patients receive replicate vaccine (the same as primary vaccine) SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 50 (1 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
* Arm 2E: Patients receive replicate vaccine (the same as primary vaccine) SC and ID on days 1, 8, 15, 29, 36, and 43 and undergo surgical biopsy at replicate vaccine site on day 85 (1 week after replicate vaccine 6). Patients are evaluated 1-3 weeks after biopsy.
Tissue biopsies are examined by reverse transcriptase-PCR, IHC, protein analysis, flow cytometry, and western blot. Blood samples are collected periodically and examined by ELIspot assay, tetramer staining, and proliferation assay.
After completion of study therapy, patients are followed annually.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Features of lymphoid neogenesis at the replicate immunization site Up to Day 85
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
University of Virginia Cancer Center🇺🇸Charlottesville, Virginia, United States