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

NCT ID: NCT00054535

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2004-09-30

Brief 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.

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.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

recombinant fowlpox-tyrosinase vaccine

Intervention Type: BIOLOGICAL

vaccinia-tyrosinase vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Suzanne L. Topalian, MD

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-03-C-0080

Identifier Type: -

Identifier Source: secondary_id

NCI-6119

Identifier Type: -

Identifier Source: secondary_id

CDR0000270794

Identifier Type: -

Identifier Source: org_study_id

NCT00051610

Identifier Type: -

Identifier Source: nct_alias