Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

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

Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
  • Determine the efficacy of these peptides in patients who cannot receive IL-2.
  • Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
  • Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
  • Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a partially randomized study.

Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.

  • Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
    • Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).
  • Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.
  • Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).
  • Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.

Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.

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
        • Surgery Branch

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 metastatic melanoma that has failed standard therapy
  • Measurable disease
  • HLA-A0201 positive

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative
  • No coagulation disorder

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No major cardiovascular disease
  • If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only

Pulmonary:

  • No major respiratory disease

Other:

  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • No active systemic infection
  • No autoimmune disease or immunodeficiency disease
  • No primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic therapy
  • No prior MART-1 antigen immunization

Chemotherapy:

  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy
  • No concurrent steroid therapy

Radiotherapy:

  • At least 3 weeks since prior radiotherapy

Surgery:

  • Prior surgery allowed

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

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

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

April 1, 1999

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

August 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067051
  • NCI-99-C-0092
  • NCI-T99-0033

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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