Intervention: H-Ile-Thr-Gln-Val-Pro-Phe-Ser-Val-OH
Trial phase: Phase 2
SMILES: CCC(C)C(N)C(=O)NC(C(=O)NC(CCC(N)=O)C(=O)NC(C(=O)N1CCCC1C(=O)NC(Cc1ccccc1)C(=O)NC(CO)C(=O)NC(C(=O)O)C(C)C)C(C)C)C(C)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
Eligibility criteria:
INCLUSION CRITERIA:

HLA-A 0201 patients, age greater than or equal to 16 years, primary melanomas with lesions that are ulcerated and greater than or equal to 2mm, or any lesions that are greater than or equal to 4.0 mm in thickness, or greater than or equal to1 positive lymph node, or local recurrence, or resected metastatic disease, within 6 months of surgical resection will be considered. Patients must be clinically disease free at the time of protocol entry as documented by radiologic studies within 6 weeks of patient entry.

Serum creatinine of 2.0 mg/dl or less

Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

WBC 3000/mm^3 or greater,

Platelet count 90,000 mm^3 or greater,

Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than three times normal,

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.

Patients may have had prior adjuvant treatment with immunotherapy, including interferon, as long as 3 weeks have elapsed since prior systemic therapy.

EXCLUSION CRITERIA:

Patients will be excluded:

Who have ocular or mucosal melanoma.

Who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer, and must have recovered to a grade I from any adverse effects of treatment prior to entry, other than those that do not have clinical implications, e.g. vitiligo, alopecia.

Have active systemic infections, autoimmune disease or any known immunodeficiency disease.

Who require systemic steroid therapy.

Who are pregnant (because of possible side effects on the fetus) or breastfeeding because of unknown effects on the developing child).

Who are known to be positive for hepatitis BsAG or human immunodeficiency virus (HIV) antibody (because of possible immune effects of these conditions).

Who have any form of autoimmune disease (such as autoimmune colitis or Crohn's Disease) or immunodeficiency as evidenced by abnormal white blood count (WBC) count 8 and/or presence of opportunistic infections. Must have recovered immune competence after radiation therapy. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)

Who have previously been immunized with gp100.

Who have known hypersensitivity to any of the agents used in this study.

Who have previously received chemotherapy for treatment of melanoma.