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Vaccine Therapy With or Without Interleukin-2 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: NCT00019669
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: aldesleukin Biological: fowlpox virus vaccine vector Biological: gp100 antigen Phase 2

Detailed Description:


  • Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2).
  • Compare the immune response in patients before and after treatment with these regimens.
  • Compare the toxicity profile of these regimens in these patients.

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

  • Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)
  • Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.)
  • Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine.

NOTE: *The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2

  • Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy.

PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
Study Start Date : October 1999
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven metastatic melanoma that has failed standard treatment
  • Measurable disease
  • HLA-A-201 positive



  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 90,000/mm^3
  • No coagulation disorders


  • Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
  • AST/ALT < 2 times normal
  • Hepatitis B surface antigen negative


  • Creatinine ≤ 2.0 mg/dL


  • No major cardiovascular disease
  • No cardiac ischemia by a stress thallium test or other comparable test*
  • No myocardial infarction*
  • No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)


  • No major respiratory disease
  • No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2


  • No autoimmune disease
  • No known immunodeficiency disease
  • No primary or secondary immunodeficiency
  • No allergy to eggs
  • No active systemic infections
  • HIV negative


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active major medical illness* NOTE: *In order to be eligible to receive IL-2


Biologic therapy:

  • No prior gp100 vaccination


  • Not specified

Endocrine therapy:

  • No concurrent steroids


  • Not specified


  • Prior surgery for the malignancy allowed


  • At least 3 weeks since other prior therapy for the malignancy

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): NCT00019669

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch

ClinicalTrials.gov Identifier: NCT00019669     History of Changes
Obsolete Identifiers: NCT00001800
Other Study ID Numbers: CDR0000066961
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: August 2004

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents