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

NCT00054535 | Completed Phase 2

• 3 other identifiers: CDR0000270794NCI-03-C-0080NCI-6119
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

recombinant fowlpox-tyrosinase vaccine BIOLOGICAL

vaccinia-tyrosinase vaccine BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Suzanne L. Topalian, MD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: January 1, 2003
• Study Completion: September 1, 2004
• Last Updated: June 19, 2013

Record last verified: 2004-07

Locations

US (1)