Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from peptides may help the body build an effective immune response
      to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system
      in different ways and stop tumor cells from growing. Giving vaccine therapy together with
      imiquimod after surgery may help the body kill any remaining tumor cells.

      PURPOSE: This randomized phase I trial is studying the side effects and best way to give
      vaccine therapy with or without imiquimod in treating patients who have undergone surgery for
      stage II, stage III, or stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope
           melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF)
           in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in
           patients who have undergone surgical resection for stage II-IV melanoma.

        -  Determine, preliminarily, the immunogenicity of these regimens in these patients.

        -  Correlate, preliminarily, transdermal administration of these vaccines with the
           recruitment and maturation of epidermal Langerhans cells in these patients.

        -  Determine, preliminarily, the effects of timing of subsequent vaccine therapy comprising
           MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered intradermally and
           subcutaneously, on the persistence of immune response in these patients.

      OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment
      arms.

        -  Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides (MP),
           tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in Montanide
           ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the vaccine
           intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and 134.

        -  Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod
           topically on days 0, 7, and 14.

        -  Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl
           sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP,
           TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113,
           and 134.

        -  Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.

      In all arms, treatment continues in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed at 3 and 5 weeks and then at
      disease progression.

      PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be
      accrued for this study within approximately 2 years.
    

Intervention name(s): incomplete Freund's adjuvant; multi-epitope melanoma peptide vaccine; sargramostim; tetanus toxoid helper peptide; dimethyl sulfoxide; imiquimod; adjuvant therapy
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Drug; Procedure
Intervention MeSH terms: Imiquimod; Sargramostim; Freund's Adjuvant; Dimethyl Sulfoxide
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II melanoma; stage III melanoma; stage IV melanoma