Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00072085
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 19, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 (210M) peptide.

Secondary

  • Compare the toxicity profile of these immunizations in these patients.

OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to HLA-A2*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms.

  • Cohort 1 (HLA-A2*0201-positive patients): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive immunization comprising recombinant gp100 protein (184V) emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1 course).
    • Arm II: Patients receive immunization comprising recombinant gp100 protein (184V) and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22, 43, and 64 (1 course).
  • Cohort 2 (HLA-A2*0201-negative patients): Patients receive immunization as in cohort 1, arm I.

In both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity.

In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2) receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3 retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment course beyond CR. Patients with progressive disease who are ineligible for IL-2 administration are removed from the study.

PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 [15-25 per treatment arm] and 15-25 for cohort 2) will be accrued for this study within 3 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen
Study Start Date : September 2003
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic melanoma
  • Measurable disease
  • Progressive disease during or after prior standard treatment with or without interleukin-2

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3
  • Lymphocyte count greater than 500/mm^3

Hepatic

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

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No symptomatic cardiac disease

Immunologic

  • No active systemic infection
  • No autoimmune disease
  • No known immunodeficiency disease
  • No known hypersensitivity to study agents
  • No form of primary or secondary immunodeficiency
  • No opportunistic infection
  • HIV negative

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior gp100 peptide vaccine

Chemotherapy

  • More than 6 weeks since prior nitrosoureas

Endocrine therapy

  • No concurrent systemic steroid therapy

Radiotherapy

  • Not specified

Surgery

  • Prior recent (within the past 3 weeks) minor surgical procedures allowed

Other

  • Recovered from prior therapy (toxicity no greater than grade 1)
  • More than 3 weeks since prior systemic anticancer therapy
  • No other concurrent systemic anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072085


Locations
Layout table for location information
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00072085     History of Changes
Obsolete Identifiers: NCT00069043
Other Study ID Numbers: CDR0000335441
NCI-03-C-0299
NCI-6210
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: May 2005

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Freund's Adjuvant
Aldesleukin
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic