Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

June 18, 2013 updated by: National Cancer Institute (NCI)

An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51.
  • Determine a safety and adverse event profile of this regimen in these patients.
  • Determine improved immunologic response in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.

Study Type

Interventional

Phase

  • Phase 2

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
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV melanoma

    • Mucosal or ocular melanoma allowed
  • Clinically evaluable disease
  • HLA-A*0201 positive

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 6 months

Hematopoietic:

  • WBC at least 2,500/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Hematocrit at least 30%

Hepatic:

  • AST no greater than 3 times upper limit of normal (ULN)
  • Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome)
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody nonreactive

Renal:

  • Creatinine less than 2.0 mg/dL

Immunologic:

  • Antinuclear antibody negative
  • Thyroglobulin antibody normal
  • Rheumatoid factor normal
  • HIV negative
  • No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
  • No active infection
  • No hypersensitivity to Montanide ISA-51

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  • No other underlying medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunotherapy for melanoma and recovered
  • No prior gp100 peptides
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Chemotherapy:

  • At least 3 weeks since prior chemotherapy for melanoma and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior hormonal therapy for melanoma and recovered
  • At least 4 weeks since prior systemic or topical corticosteroids
  • No concurrent topical or systemic corticosteroids

Radiotherapy:

  • At least 3 weeks since prior radiotherapy for melanoma and recovered

Surgery:

  • Not specified

Other:

  • No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

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

January 1, 2002

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069251
  • NCI-02-C-0106H
  • NCI-5743

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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