RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor
cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
Combining vaccine therapy and interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without
interleukin-2 in treating patients with metastatic melanoma that has not responded to
OBJECTIVES: I. Determine the clinical response of patients receiving DNA gp100 antigen
alone or in combination with interleukin-2 for recurrent metastatic melanoma.
II. Identify the immunologic response in these patients prior to and after these
III. Determine the toxicity of these treatments in these patients.
PROTOCOL OUTLINE: Patients are accrued for the first three cohorts and the study proceeds to
the final two cohorts if responses are observed.
Cohort I: Patients receive gp100 antigen intramuscularly (IM) into each of 2 proximal
extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort II:
Patients receive gp100 antigen intradermally (ID) at 5 sites on each of 2 proximal
extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort III:
Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for
up to 4 doses. If patients do not exhibit immunologic response or dose-limiting toxicity,
they may receive a higher dose of gp100 antigen on subsequent courses.
Cohort IV: If cohorts I, II, or III do not produce an immune response and do not experience
dose-limiting toxicity, patients receive a higher dose of gp100 antigen IM into each of 2
proximal extremities every 4 weeks for up to 4 doses.
Cohort V: Patients receive gp100 antigen IM or ID at the dose found to produce immunization
once every 4 weeks for up to 4 doses. Patients also receive interleukin-2 IV over 15
minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen.
Patients with minor, mixed, or partial response or stable disease may receive additional
courses of treatment following 3-4 weeks of rest. Patients receive a maximum of 12 courses.
Patients are followed at 4-6 weeks.
A maximum of 65 patients will be accrued for this study within 1 year.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Diagnosis of metastatic melanoma that has failed standard
therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks
since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy
Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid
therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Prior surgery
allowed --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0 or 1 Life
expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at
least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL
ALT/AST less than 2 times normal Hepatitis B surface antigen negative Renal: Creatinine no
greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major
respiratory disease Other: Not pregnant Negative pregnancy test Fertile patients must use
effective contraception No active systemic infections No autoimmune disease No primary or
secondary immunodeficiency HIV negative