Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00470015
First received: May 3, 2007
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: MART-1 antigen
Biological: IL-2
Biological: gp100 antigen
Biological: GM-CSF
Biological: MART-1a peptide
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number and severity of hematologic and nonhematologic toxicities observed at each dose level [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Delayed-type hypersensitivity positivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MART1 Analog, gp100 and Survivin Biological: MART-1 antigen
1000 mcg; Day 1 of a 21 day cycle x 4
Biological: IL-2
0.5x10^6/m^2
Other Name: Interleukin-2, Proleukin®, aldesleukin
Biological: gp100 antigen
1000 mcg; Day 1 of a 21 day cycle x 4
Biological: GM-CSF
300mcg
Other Name: Leukine-Liquid, sargramostatin
Biological: MART-1a peptide
1000 mcg; Day 1 of a 21 day cycle x 4

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470015

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00470015     History of Changes
Other Study ID Numbers: CDR0000542631, P30CA015083, MC0575, 06-002650, NCI-2009-1306
Study First Received: May 3, 2007
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 24, 2014