Vaccine Therapy in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill
      tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with
      either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.

      PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide
      946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with
      metastatic melanoma that cannot be surgically removed or with melanoma that is likely to
      recur.
    

Detailed description: 
      OBJECTIVES:

      I. Determine the safety of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined
      with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients
      with high risk melanoma.

      II. Determine the immunogenicity of peptide 946 melanoma vaccine (peptide 946), peptide 946
      combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in
      patients with high risk melanoma.

      OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment
      arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with QS21
      subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide ISA-51
      (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide melanoma
      vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide 946
      combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide
      946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide
      946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are randomized
      to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities are observed
      in these patients, then additional patients are randomized to arms III-VI. Patients in each
      arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients are followed at 6
      and 12 months.

      PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
    

Intervention name(s): QS21; IFA (incomplete Freund's adjuvant); p946; p946/tet-p; Tet-p
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): vaccine adjuvant; Peptides emulsified in IFA.; This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.; This peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p); modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
Other intervention name(s): Montanide ISA-51, from Seppic.; peptide 946, gp100 [280-288], YLEPGPVTA; peptide 946-tetanus peptide conjugate melanoma vaccine; tetanus peptide melanoma vaccine
Intervention MeSH terms: Vaccines; Freund's Adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma