Melanoma (Skin) Clinical Trial
Official title:
A Multipeptide Vaccine in Melanoma Patients With Evaluation of the Injection Site Microenvironment
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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