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

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00054535
• Collaborator: (none)
• Location: 1
• Duration (Months): 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: aldesleukin; Biological: recombinant fowlpox-tyrosinase vaccine; Biological: vaccinia-tyrosinase vaccine	Phase 2

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.

Study Design

• Study Type: Interventional
• Masking: None (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
• Study Start Date: Jan 1, 2003
• Actual Study Completion Date: Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Study Chair: Suzanne L. Topalian, MD, NCI - Surgery Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00054535
• Other Study ID Numbers: CDR0000270794; NCI-03-C-0080; NCI-6119; NCT00051610
• First Posted: Feb 6, 2003
• Last Update Posted: Jun 19, 2013
• Last Verified: Jul 1, 2004

• Keywords provided by , ,: stage IV melanoma; recurrent melanoma
• Additional relevant MeSH terms: Melanoma; Aldesleukin; Vaccines

Study Results

No Results Posted as of Jun 19, 2013