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Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

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 SupportBethesda, Maryland  20892-1182