Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Inclusion Criteria

Any patient age greater than or equal to 18 with measurable metastatic melanoma who has
failed standard treatment and has an expected survival of greater than three months will
be considered.

Serum creatinine of 2.0 mg/dl or less.

Bilirubin 1.6 mg/dl or less.

WBC 3000/mm(3) or greater.

Platelet count 90,000 mm(3) or greater.

Serum AST/ALT less then two times normal.

ECOG performance status of 0 or 1 or 2.

Patients of both genders must be willing to practice effective birth control during this
trial.

No patients who are undergoing or have undergone in the past 3 weeks any other form of
therapy except surgery for their cancer.

No patients who have active systemic infections, coagulation disorders, autoimmune disease
or other major medical illnesses of the cardiovascular or respiratory systems or any known
immunodeficiency disease. Patients with cardiovascular disease will be eligible to
receive peptide in IFA alone.

No patients who require steroid therapy.

No patients who are pregnant (because of possible side effects on the fetus).

No patients who are known to be positive for hepatitis BsAG or HIV antibody (because of
possible immune effects of these conditions).

No patients who have any form of primary or secondary immunodeficiency. (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).