Vaccine Therapy in Treating Patients With Melanoma

Study Overview
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Brief Summary
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Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery. Vaccines may make the body build an immune response that may kill tumor cells. Combining more than one vaccine may kill more tumor cells.

Detailed Description
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OBJECTIVES: I. Determine the toxic effects associated with ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma. II. Characterize the inflammatory and lymphokine response to this regimen in these patients. III. Examine the extent of nodule regression, humoral immune response, and cytolytic T cell activity with this regimen in these patients. OUTLINE: This is a dose escalation study of ALVAC-hB7.1 Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity. Patients are followed at 1, 2, 4, 8, 11, 15, 22, and 43 days after the first vaccination.

Official Title
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Phase Ib Trial of Intratumoral Injection of a Recombinant Canarypox Virus Encoding Human B7.1 (ALVAC-hB7.1) or a Combination of ALVAC-hB7.1 and a Recombinant Canarypox Virus Encoding Human Interleukin 12 (ALVAC-hIL-12) in Patients With Surgically Incurable Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: ALVAC-hB7.1
* Biological: canarypox-hIL-12 melanoma vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed melanoma that is surgically incurable At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection If only one accessible lesion is available, it must be at least 2 cm If two or more accessible lesions exist, then none of them are required to be at least 2 cm PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Leukocyte count at least 3,000/mm3 Platelet count at least 120,000/mm3 SGOT and alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis) BUN less than 40 mg/dL Creatinine less than 2.5 mg/dL No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias Not positive for hepatitis B virus Not positive for HIV No history of allergy to vaccinia virus No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No underlying immunodeficiency disorder PRIOR CONCURRENT THERAPY: At least 30 days since prior biologic therapy (e.g., interferon or IL-2) At least 30 days since prior chemotherapy No concurrent steroids At least 30 days since prior radiotherapy Prior radiotherapy to no greater than 50% of nodal groups No prior splenectomy No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity. | Biological: ALVAC-hB7.1<br> <br> Biological: canarypox-hIL-12 melanoma vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma