Overview

This trial is active, not recruiting.

Condition melanoma (skin)
Treatments mart-1 antigen, il-2, gp100 antigen, gm-csf, mart-1a peptide
Phase phase 1
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date March 2007
End date April 2009
Trial size 20 participants
Trial identifier NCT00470015, 06-002650, CDR0000542631, MC0575, NCI-2009-1306, P30CA015083

Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mart-1 antigen
1000 mcg; Day 1 of a 21 day cycle x 4
il-2 Interleukin-2, Proleukin®, aldesleukin
0.5x10^6/m^2
gp100 antigen
1000 mcg; Day 1 of a 21 day cycle x 4
gm-csf Leukine-Liquid, sargramostatin
300mcg
mart-1a peptide
1000 mcg; Day 1 of a 21 day cycle x 4

Primary Outcomes

Measure
Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels
time frame: 12 weeks
Number and severity of hematologic and nonhematologic toxicities observed at each dose level
time frame: 12 weeks

Secondary Outcomes

Measure
Delayed-type hypersensitivity positivity
time frame: 12 weeks
Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels
time frame: 12 weeks
Time to treatment failure
time frame: 12 weeks
Time to progression
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed melanoma - Stage II-IV disease - Completely resected disease - No known standard therapy that is potentially curative or proven capable of extending life expectancy exists - HLA-A2 positive PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy ≥ 12 weeks - ANC ≥ 1,500/mm³ - Hemoglobin > 10 g/dL - Platelet count ≥ 50,000/mm³ - AST ≤ 3 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 3 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled or current infection - No known allergy to vaccine or immunoadjuvant components - No known immune deficiency PRIOR CONCURRENT THERAPY: - No chemotherapy within the past 4 weeks and recovered - No biologic therapy within the past 4 weeks - No radiation therapy within the past 4 weeks

Additional Information

Official title Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study
Description OBJECTIVES: - Determine the safety and toxicity profile of peptide vaccine comprising MART-1 antigen, gp100 antigen, and survivin antigen in combination with sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (IFA) with or without low-dose aldesleukin in patients with stage II-IV melanoma. - Determine the immunologic effects of two different doses of GM-CSF coemulsified with melanoma peptides in IFA in these patients. - Determine the immunological effects of low-dose aldesleukin therapy administered after peptide immunization in these patients. - Collect preliminary data on the impact of the vaccine on clinical outcomes in these patients. OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules. - Dose schedule 1: Patients receive gp100 antigen, MART-1 antigen, survivin antigen, and sargramostim (GM-CSF) emulsified in incomplete Freund's adjuvant (peptide vaccine) subcutaneously (SC) on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Dose schedule 2: Patients receive peptide vaccine as in group 1. Patients also receive low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Dose schedule 3: Patients receive peptide vaccine as in group 1 except with a higher dose of GM-CSF. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Dose schedule 4: Patients receive peptide vaccine as in group 1 except with a higher dose of GM-CSF. Patients also receive low-dose aldesleukin SC twice daily on days 7-20. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first course. After completion of study therapy, patients are followed every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.