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

September 11, 2000
February 6, 2009
October 2000
 
 
 
Complete list of historical versions of study NCT00006243 on ClinicalTrials.gov Archive Site
 
 
 
Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and gp-100) as Immune Targets

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.

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.

Phase I
Interventional
Treatment, Randomized, Active Control
Melanoma (Skin)
  • Biological: MART-1 antigen
  • Biological: gp100 antigen
  • Biological: incomplete Freund's adjuvant
  • Biological: sargramostim
  • Biological: tyrosinase peptide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006243
 
CDR0000068171, MAYO-9973, NCI-T99-0083
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
November 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP