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Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000542631

NCT ID:

NCT00470015

Start Date:

March 2007

Completion Date:

December 2013

Related Keywords:

  • Melanoma (Skin)
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Mayo ClinicRochester, Minnesota  55905