Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia Identifier:
First received: August 4, 2004
Last updated: December 18, 2014
Last verified: December 2014

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Enrollment: 7
Study Start Date: August 2002
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.

OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.


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


  • Diagnosis of melanoma

    • Unresectable stage III or IV disease
    • Mucosal or ocular disease allowed
  • Positive HLA-A1, -A2, or -A3 expression



  • 12 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


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


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


  • Creatinine ≤ 1.5 times ULN


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


  • Weight ≥ 100 pounds
  • Not pregnant or nursing
  • No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix


Biologic therapy

  • No prior vaccination with any of the peptides used in this protocol
  • More than 1 year since prior melanoma vaccine therapy
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior growth factors
  • More than 4 weeks since prior allergy shots


  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior steroid therapy


  • More than 4 weeks since prior radiotherapy


  • Prior tumor resection allowed
  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 identifier: NCT00089206

United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
Study Chair: Craig L. Slingluff, MD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Craig L Slingluff, Jr, Professor of Surgery, University of Virginia Identifier: NCT00089206     History of Changes
Other Study ID Numbers: 10049, UVACC-MEL-42, UVACC-24802
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 III melanoma
stage IV melanoma
recurrent melanoma
recurrent intraocular melanoma
iris melanoma
extraocular extension melanoma
ciliary body and choroid melanoma, medium/large size

Additional relevant MeSH terms:
Uveal Neoplasms
Eye Diseases
Eye Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Uveal Diseases
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 24, 2015