Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 16 and over NCI NCI-99-C-0095 NCI-T99-0025, T99-0025, NCT00019734

Special Category: NIH Clinical Center trial

Objectives

1. 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.
2. 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.
3. Determine the immunological response in patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

A total of 73 patients (13-20 for arm I, 13-20 for arm II, and 19-33 for arm III) will be accrued for this study within 2 years.

Outline

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

• Arm I: Patients receive recombinant fowlpox vaccine IM on day 1 followed 4 weeks later by recombinant vaccinia vaccine IM. Treatment repeats for a minimum of 4 vaccinations.



• Arm II: Patients receive vaccinations as in arm I plus low-dose interleukin-2 (IL-2) subcutaneously daily on days 2-13 after each vaccination.



• Arm III: Patients receive vaccinations as in arm I plus high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 after each vaccination.

Patients with stable disease or a minor, mixed, or partial response after four immunizations (1 course) may receive a second course of the same regimen beginning 4-6 weeks after the first course. After the second course, patients with tumor regression may continue to receive treatment in the absence of unacceptable toxicity until best response is achieved.

Patients are followed at 4-6 weeks.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Suzanne Topalian, MD, Protocol chair(Contact information may not be current)		Ph: 866-820-4505 Email: stopalian@nih.gov

Registry Information
Official Title		Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
Trial Start Date		1999-07-19
Registered in ClinicalTrials.gov		NCT00019734
Date Submitted to PDQ		1999-05-07
Information Last Verified		2007-05-31