Vaccine Therapy in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: QS21; IFA (incomplete Freund's adjuvant); p946; p946/tet-p; Tet-p
Intervention description: 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.
Intervention MeSH terms: Vaccines; Freund's Adjuvant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma

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.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR
             resected melanoma with high risk of recurrence or mortality (stage IIB and above)

          -  Age: 18 to 79

          -  Performance status: ECOG 0-2

          -  Life expectancy: Greater than 12 months

          -  Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater
             than 100,000/mm3 Hemoglobin greater than 9 g/dL

          -  Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin
             no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN

          -  Renal: Creatinine no greater than 1.5 times ULN

        Exclusion criteria:

          -  patients currently receiving cytotoxic chemotherapy or who have received that therapy
             within the preceding 3 months

          -  known or suspected allergies to any component of the treatment vaccine

          -  unresectable tumor llikely to cause symptoms and for which therapy is anticipated
             within 3 months.

          -  receiving acute treatment for seriouis infection within 14 days.

          -  Patients with bulky disease, or with multiple brain metastases, but solitary brain
             metastases treated successfully with surgery or gamma knife may be eligible.

          -  Any of the following with 3 months:

          -  agentes with putative immunomodulating activity (except NSAIDs)

          -  allergy desensitizing injections

          -  other investigational agents

          -  interferons

          -  corticosteroids

          -  any growth factors

          -  prior melanoma vaccinations

          -  pregnancy or the possibility of becoming pregnant on study

          -  medical contraindication or potential problems in complying with the requirements of
             the protocol.