Clinical Trial: Vaccine Therapy in Treating Patients With Advanced Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multipeptide Vaccine in Melanoma Patients With Evaluation of the Injection Site Microenvironment

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 Summary:

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 rep
    Sponsor: Craig L Slingluff, Jr

    Current Primary Outcome: Features of lymphoid neogenesis at the replicate immunization site [ Time Frame: Up to Day 85 ]

    Original Primary Outcome: Features of lymphoid neogenesis at the replicate immunization site

    Current Secondary Outcome:

    Original Secondary Outcome:

    • Proliferating T cells in the replicate immunization site
    • Toll-like receptor signaling in the replicate immunization site
    • Regulatory processes in the replicate immunization sites
    • CD8+ and CD4+ peptide-reactive T-cell responses among lymphocytes infiltrating skin at the replicate immunization sites and in the peripheral blood
    • CCR and integrin expression on vaccine-induced T cells in the peripheral blood and at the replicate immunization site


    Information By: University of Virginia

    Dates:
    Date Received: June 25, 2008
    Date Started: May 2008
    Date Completion:
    Last Updated: December 15, 2016
    Last Verified: December 2016