Vaccine Therapy in Treating Patients With Melanoma
- Conditions
- Melanoma (Skin)
- Interventions
- Biological: ALVAC-hB7.1Biological: canarypox-hIL-12 melanoma vaccine
- Registration Number
- NCT00003556
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I 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. Arm I canarypox-hIL-12 melanoma vaccine 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States