Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma
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.
Primary Purpose: Treatment
Steven A. Rosenberg
National Cancer Institute (NCI)
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|