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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert M. Conry, MD
University of Alabama at Birmingham
United States: Food and Drug Administration
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|