Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00019734 | Completed Phase 2

• 3 other identifiers: CDR0000067075NCI-99-C-0095NCI-T99-0025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous treatment.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

fowlpox virus vaccine vector 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: * Histologically confirmed metastatic melanoma that has failed standard treatment * No ocular or mucosal melanoma as primary site * Measurable disease * No existing brain metastases PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0 or 1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 90,000/mm3 * No coagulation disorder Hepatic: * Bilirubin no greater than 1.6 mg/dL * AST/ALT less than 3 times normal * Hepatitis B surface antigen 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 primary or secondary immunodeficiency * No allergy to eggs * No history of allergy or untoward reaction to prior smallpox vaccination Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination * No active systemic infections * No active atopic dermatitis or active or past history of eczema * No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds * Surgical scars must be healed * Healed surgical stomas (e.g., colostomy) allowed PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior recombinant vaccinia or fowlpox vaccines for melanoma * At least 3 weeks since prior systemic biologic therapy for melanoma Chemotherapy: * At least 3 weeks since prior systemic chemotherapy for melanoma Endocrine therapy: * At least 3 weeks since prior systemic endocrine therapy for melanoma * No concurrent steroid therapy Radiotherapy: * At least 3 weeks since prior systemic radiotherapy for melanoma Surgery: * Prior surgery allowed

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)

Surgery Branch

Bethesda, Maryland, 20892, 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
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: May 28, 2003
• Study Start: July 1, 1999
• Study Completion: May 1, 2003
• Last Updated: June 20, 2013

Record last verified: 2007-05

Locations

US (1)