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
I. To identify whether the addition of the peptide vaccine to high dose 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.
I. To evaluate the toxicity profile of patients treated on this trial, according to the
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
IV. To evaluate the quality of life of patients before and after high-dose IL-2.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease site (cutaneous or subcutaneous only vs any other site with or without subcutaneous
disease). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses.
ARM II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day
1. Patients also receive IL-2 as in arm I beginning on day 2.
In both arms, treatment repeats every 3 weeks for 2 courses. 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.
Quality of life is assessed before and after the first course of IL-2.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 93-185 patients (46-93 per treatment arm) will be accrued for
this study within 2 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Best response rate (partial response [PR] + complete response [CR])
The Chi-squared test will be used for evaluating differences in response rates. Stratified analyses, such as Thomas's test for combining Fisher's exact tests could be used as part of the stratified analysis as well.
Up to 12 years
Indiana University Health Goshen Center for Cancer Care
United States: Food and Drug Administration
|Indiana University Health Goshen Center For Cancer Care||Goshen, Indiana 46526|