Vaccine Therapy in Treating Patients With Metastatic Melanoma

Launched by NATIONAL CANCER INSTITUTE (NCI) · May 27, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine efficacy of recombinant fowlpox and vaccinia viruses encoding tyrosinase antigen, administered with or without low-dose interleukin-2 (IL-2), in terms of response, in patients with metastatic melanoma.
* Compare the response rate in patients to this vaccination administered with high-dose IL-2 to that in similar patients on previous trials treated with high-dose IL-2 alone.
* Determine the immunological response in patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms.

* Arm I: Patients rece...

Gender

ALL

Eligibility criteria

• 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