Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

Stage IV Melanoma Clinical Trial

Official title: Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma

Status Completed

Clinical Trial Summary

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 previous treatment.

Clinical Trial Description

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 treatments.

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.

PROJECTED ACCRUAL:

A maximum of 65 patients will be accrued for this study within 1 year. ;

Related Conditions & MeSH terms

• Melanoma
• Recurrence
• Recurrent Melanoma
• Stage IV Melanoma

• NCT number: NCT00019448
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: September 1998
• Completion date: March 2007