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

November 18, 2014 updated by: Craig L Slingluff, Jr, University of Virginia

Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • incomplete Freund's adjuvant, Montanide ISA-51
Biological: 6MHP
melanoma helper peptides
Other Names:
  • multi-epitope melanoma peptide vaccine
Biological: GM-CSF
vaccine adjuvant
Other Names:
  • 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 Names:
  • incomplete Freund's adjuvant, Montanide ISA-51
Biological: 6MHP
melanoma helper peptides
Other Names:
  • multi-epitope melanoma peptide vaccine
Biological: GM-CSF
vaccine adjuvant
Other Names:
  • 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 Names:
  • incomplete Freund's adjuvant, Montanide ISA-51
Biological: 6MHP
melanoma helper peptides
Other Names:
  • multi-epitope melanoma peptide vaccine
Biological: GM-CSF
vaccine adjuvant
Other Names:
  • sargramostim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Dose-limiting toxicity
Time Frame: During study period
Toxicities measured by CTCAE.
During study period
Immunogenicity
Time Frame: day 22
Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.
day 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response in the blood
Time Frame: day 50
Immune response measured in the blood, by proliferation assay, over time during the study.
day 50
DTH response
Time Frame: by day 85
Delayed-type hypersensitivity response to tumor peptides
by day 85
Clinical outcome
Time Frame: during the study
Clinical tumor response
during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 4, 2004

First Submitted That Met QC Criteria

August 4, 2004

First Posted (Estimate)

August 5, 2004

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10464 (Other Identifier: CTEP)
  • UVACC-MEL-41
  • UVACC-28502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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