NCT00019682

Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma

A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.

Detailed description

PRIMARY OBJECTIVES: I. To identify whether the addition of the peptide vaccine to high dose interleukin (IL)-2 (aldesleukin) can result in a clinical response rate which may be superior to that found in similar patients treated with high dose IL-2 alone. SECONDARY OBJECTIVES: I. To evaluate the toxicity profile of patients treated on this trial, according to the regimen received. II. To compare the disease free/progression free survival of patients treated on both arms of the study. III. To determine the immunologic response experienced by patients who have received the peptide vaccination, as measured by changes in T-cell precursors from before to after treatment. IV. To evaluate the quality of life of patients before and after high-dose IL-2. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive aldesleukin intravenously (IV) over 15 minutes every 8 hours for 12 doses. ARM II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously (SC) on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. In both arms, treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses. After completion of treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions

• Recurrent Melanoma
• Stage IIIA Skin Melanoma
• Stage IIIB Skin Melanoma
• Stage IIIC Skin Melanoma
• Stage IV Skin Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given IV
BIOLOGICAL	gp100 Antigen	Given SC
DRUG	Montanide ISA 51 VG	Given SC
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 1999-12-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2003-01-27
• Last updated: 2017-11-20
• Results posted: 2017-11-20

Locations

19 sites across 1 country: United States