Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
16 Years
N/A
Both
Melanoma (Skin)
Trial Information
Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Suzanne L. Topalian, MD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Surgery Branch
Authority:
United States: Federal Government
Study ID:
CDR0000270794
NCT ID:
NCT00054535
Start Date:
January 2003
Completion Date:
September 2004
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
