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Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 5, 2003
Last updated: June 18, 2013
Last verified: July 2004

RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.

Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: recombinant fowlpox-tyrosinase vaccine
Biological: vaccinia-tyrosinase vaccine
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
Study Completion Date: September 2004
Detailed Description:


  • Determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2.
  • Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen.

OUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. Patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course beyond achieving CR.

Patients are followed annually for at least 5 years.

PROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.


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


  • Diagnosis of metastatic melanoma

    • Measurable disease
    • Disease progression while receiving prior standard treatment
    • No ocular or mucosal primary site
  • No uncontrolled brain metastases



  • 16 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months


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


  • Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine no greater than 1.6 mg/dL


  • No major cardiovascular illness


  • No major respiratory illness


  • HIV negative
  • No autoimmune disease
  • No active systemic infections
  • No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation)
  • No allergy to eggs
  • No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No close contact with the following individuals for 2 weeks after vaccinia vaccination:

    • Children under 5 years of age
    • Pregnant women
    • Individuals with prior or active eczema or other eczematoid skin disorders
    • Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
    • Immunosuppressed individuals
  • No active atopic dermatitis
  • No prior or active eczema
  • No active cases of the following conditions:

    • Extensive psoriasis
    • Severe acneiform rash
    • Impetigo
    • Varicella zoster
    • Burns
    • Traumatic or pruritic skin conditions
    • Open wounds
  • No unhealed surgical scars

    • Healed surgical stomas (e.g., colostomy) allowed


Biologic therapy

  • No prior recombinant vaccinia or fowlpox vaccines for melanoma
  • No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma

    • Prior individual tyrosinase peptides are allowed
  • No prior high-dose interleukin-2


  • Not specified

Endocrine therapy

  • No concurrent oral, IV, topical, or inhaled steroids


  • Not specified


  • Recovered from prior surgery


  • Recovered from prior therapy for melanoma
  • More than 3 weeks since prior systemic therapy for melanoma
  • No other concurrent systemic therapy for melanoma
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00054535

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: Suzanne L. Topalian, MD NCI - Surgery Branch
  More Information Identifier: NCT00054535     History of Changes
Obsolete Identifiers: NCT00051610
Other Study ID Numbers: CDR0000270794
Study First Received: February 5, 2003
Last Updated: June 18, 2013

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
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 21, 2017