Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

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:
NCT00089219
First received: August 4, 2004
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: IFA
Biological: 6MHP
Biological: GM-CSF
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Safety: Dose-limiting toxicity [ Time Frame: During study period ] [ Designated as safety issue: Yes ]
    Toxicities measured by CTCAE.

  • Immunogenicity [ Time Frame: day 22 ] [ Designated as safety issue: No ]
    Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.


Secondary Outcome Measures:
  • Immune response in the blood [ Time Frame: day 50 ] [ Designated as safety issue: No ]
    Immune response measured in the blood, by proliferation assay, over time during the study.

  • DTH response [ Time Frame: by day 85 ] [ Designated as safety issue: No ]
    Delayed-type hypersensitivity response to tumor peptides

  • Clinical outcome [ Time Frame: during the study ] [ Designated as safety issue: No ]
    Clinical tumor response


Enrollment: 39
Study Start Date: July 2003
Arms Assigned Interventions
Experimental: Arm A. 6MHP vaccine 200 mcg
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Biological: IFA
vaccine adjuvant
Other Name: incomplete Freund's adjuvant, Montanide ISA-51
Biological: 6MHP
melanoma helper peptides
Other Name: multi-epitope melanoma peptide vaccine
Biological: GM-CSF
vaccine adjuvant
Other Name: sargramostim
Experimental: Arm B. 6MHP vaccine 400 mcg
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Biological: IFA
vaccine adjuvant
Other Name: incomplete Freund's adjuvant, Montanide ISA-51
Biological: 6MHP
melanoma helper peptides
Other Name: multi-epitope melanoma peptide vaccine
Biological: GM-CSF
vaccine adjuvant
Other Name: sargramostim
Experimental: Arm C. 6MHP vaccine 800 mcg
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Biological: IFA
vaccine adjuvant
Other Name: incomplete Freund's adjuvant, Montanide ISA-51
Biological: 6MHP
melanoma helper peptides
Other Name: multi-epitope melanoma peptide vaccine
Biological: GM-CSF
vaccine adjuvant
Other Name: sargramostim

Detailed Description:

OBJECTIVES:

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

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
  • Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
  • Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage IIIB, IIIC, or IV melanoma
  • HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
  • Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS:

Age

  • 18 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

  • Prior diagnosis of other cancer allowed
  • Not pregnant or nursing
  • Weight ≥ 110 pounds
  • No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior growth factors
  • More than 4 weeks since prior allergy shots
  • 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
  • No prior vaccination with any of the peptides used in this study

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

Other

  • More than 1 month since prior investigational drugs or therapies
  • No other concurrent investigational drugs or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089219

Locations
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Study Chair: Craig L. Slingluff, MD University of Virginia
  More Information

Additional Information:
Publications:
Responsible Party: Craig L Slingluff, Jr, Professor of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT00089219     History of Changes
Other Study ID Numbers: 10464, UVACC-MEL-41, UVACC-28502
Study First Received: August 4, 2004
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
stage III melanoma
stage IV melanoma
recurrent melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
recurrent intraocular melanoma

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

ClinicalTrials.gov processed this record on April 17, 2014