Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00089193
First received: August 4, 2004
Last updated: February 6, 2009
Last verified: March 2005

August 4, 2004
February 6, 2009
September 2003
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Complete list of historical versions of study NCT00089193 on ClinicalTrials.gov Archive Site
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Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides

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. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients with stage II B, stage IIC, stage III, or stage IV melanoma.

OBJECTIVES:

  • Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim (GM-CSF).
  • Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site.
  • Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites.
  • Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site.
  • Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites.

In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52.

PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: incomplete Freund's adjuvant
  • Biological: multi-epitope melanoma peptide vaccine
  • Biological: sargramostim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma

    • Stage IIB, IIC, III, or IV disease
  • Must express HLA-A1, -A2, or -A3
  • No ocular melanoma

PATIENT CHARACTERISTICS:

Age

  • 12 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 9 g/dL

Hepatic

  • Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

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

Other

  • Not pregnant or nursing
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior growth factors
  • More than 4 weeks since prior allergy shots
  • No prior vaccine therapy for melanoma or any other cancer with any of the peptides used in this study
  • More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine

Chemotherapy

  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior steroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • Not specified
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089193
CDR0000378169, UVACC-MEL-43, UVACC-28903, UVACC-HIC-10524, FCCC-03045, MDA-2003-0720
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University of Virginia
National Cancer Institute (NCI)
Study Chair: Craig L. Slingluff, MD University of Virginia
National Cancer Institute (NCI)
March 2005

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