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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia
ClinicalTrials.gov Identifier:
NCT00089193
First received: August 4, 2004
Last updated: December 18, 2014
Last verified: December 2014
  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. 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.


Condition Intervention Phase
Melanoma (Skin)
Biological: incomplete Freund's adjuvant
Biological: multi-epitope melanoma peptide vaccine
Biological: sargramostim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Study Start Date: September 2003
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00089193

Locations
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Craig L Slingluff, Jr
Investigators
Study Chair: Craig L. Slingluff, MD University of Virginia
  More Information

Additional Information:
No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Craig L Slingluff, Jr, Professor, Department of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT00089193     History of Changes
Other Study ID Numbers: 10524, UVACC-MEL-43, FCCC-03045, MDA-2003-0720
Study First Received: August 4, 2004
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

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

ClinicalTrials.gov processed this record on July 30, 2015