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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054535
• Other study ID #: CDR0000270794
• Secondary ID: NCI-03-C-0080NCI
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: June 18, 2013
• Start date: January 2003
• Est. completion date: September 2004

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00051610

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

• recombinant fowlpox-tyrosinase vaccine

• vaccinia-tyrosinase vaccine

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,