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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia
ClinicalTrials.gov Identifier:
NCT00089206
First received: August 4, 2004
Last updated: June 17, 2013
Last verified: June 2013

August 4, 2004
June 17, 2013
August 2002
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Complete list of historical versions of study NCT00089206 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Intraocular Melanoma
  • 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

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

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

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior steroid therapy

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • Prior tumor resection allowed
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089206
10049, UVACC-MEL-42, UVACC-24802
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Craig L Slingluff, Jr, University of Virginia
University of Virginia
National Cancer Institute (NCI)
Study Chair: Craig L. Slingluff, MD University of Virginia
University of Virginia
June 2013

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