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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054535
First received: February 5, 2003
Last updated: June 18, 2013
Last verified: July 2004
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic melanoma

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

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

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

Hepatic

  • 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

Renal

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular

  • No major cardiovascular illness

Pulmonary

  • No major respiratory illness

Immunologic

  • 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)

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • Not specified

Endocrine therapy

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

Radiotherapy

  • Not specified

Surgery

  • Recovered from prior surgery

Other

  • 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 ClinicalTrials.gov identifier: NCT00054535

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Suzanne L. Topalian, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054535     History of Changes
Obsolete Identifiers: NCT00051610
Other Study ID Numbers: CDR0000270794, NCI-03-C-0080, NCI-6119
Study First Received: February 5, 2003
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014