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

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00470015

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
Melanoma (Skin)	Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: survivin antigen

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Aldesleukin Sargramostim Freund's adjuvant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Delayed-type hypersensitivity positivity [ Designated as safety issue: No ]
Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels [ Designated as safety issue: No ]
Time to treatment failure [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Svetomir Markovic, MD, PhD	Mayo Clinic
Investigator:	Mark R. Pittelkow, MD	Mayo Clinic
Investigator:	Ravi D. Rao, MD, MBBS	Mayo Clinic
Investigator:	Edward T. Creagan, MD	Mayo Clinic
Investigator:	Judith S. Kaur, MD	Mayo Clinic
Investigator:	Lori A. Erickson, MD	Mayo Clinic
Investigator:	Henry C. Pitot, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000542631, MAYO-MC0575
Study First Received:	May 3, 2007
Last Updated:	April 11, 2009
ClinicalTrials.gov Identifier:	NCT00470015 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:

Anti-HIV Agents
Immunologic Factors
Adjuvants, Immunologic
Antiviral Agents
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Aldesleukin
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Freund's Adjuvant
Nevus

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Freund's Adjuvant

ClinicalTrials.gov processed this record on May 07, 2009