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Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
This study has been completed.
First Received: September 11, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006243
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: This randomized phase I trial is studying giving melanoma vaccine together with sargramostim to see how well it works compared to melanoma vaccine alone in treating patients with stage IV malignant melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: MART-1 antigen
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Biological: sargramostim
Biological: tyrosinase peptide
Phase I

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Tyrosinase Freund's adjuvant
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and gp-100) as Immune Targets

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

Study Start Date: October 2000
Detailed Description:

OBJECTIVES:

  • Compare the immune responses of patients with HLA-A2 positive stage IV malignant melanoma treated with tyrosinase, MART-1, and gp100 antigens emulsified in Montanide ISA-51 with or without sargramostim (GM-CSF).
  • Compare the safety and toxicity of these regimens in these patients.
  • Collect preliminary data on therapeutic efficacy relating to parameters of immune function in these patients on these treatments.

OUTLINE: This is a randomized study. Patients are stratified according to dominant disease (visceral vs nonvisceral). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive melanoma specific antigen peptides comprising tyrosinase, gp100, and MART 1:27-35 emulsified in Montanide ISA-51 subcutaneously. Vaccinations are administered at the site of the primary melanoma, and in the abdomen and the extremities (6 total injections per session) every 3 weeks for 6 months. Patients may then continue receiving vaccinations every 3 months for 1 year.
  • Arms II and III: Patients receive vaccinations as in arm I, combined with two different concentrations of sargramostim (GM-CSF).

Patients are followed every 3 months until year 3.

PROJECTED ACCRUAL: A total of 30 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 proven stage IV malignant melanoma that is refractory to standard treatment or for which no curative therapy exists
  • Measurable disease
  • HLA-A2 positive
  • No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 9.0 g/dL

Hepatic:

  • Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association classification III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent seizure disorder
  • No active concurrent psychiatric disorder requiring antipsychotic medication
  • No concurrent uncontrolled infection
  • No immune deficiency
  • No other malignancy within the past 5 years except locally resected basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior tyrosinase peptide, gp100 antigen, or MART-1:27-35 antigen
  • At least 4 weeks since prior biologic therapy or immunotherapy
  • No other concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (at least 6 weeks since prior mitomycin or nitrosoureas) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy involving no more than 25% of bone marrow
  • No concurrent radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006243

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
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

Study ID Numbers: CDR0000068171, MAYO-9973, NCI-T99-0083
Study First Received: September 11, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006243     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Immunologic Factors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Adjuvants, Immunologic
Neuroepithelioma
Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Freund's Adjuvant

ClinicalTrials.gov processed this record on May 06, 2009