Phase I Bridging Trial of TG4010 as Antigen-Specific Immunotherapy in Patients With MUC-1 Positive Advanced Cancer
OBJECTIVES: I. Determine the safety, tolerance, and maximum tolerated dose of TG4010 in
patients with MUC1 positive advanced cancer. II. Determine the biological and immunological
effects of this regimen in this patient population.
OUTLINE: This is a dose escalation study. Patients receive TG4010 IM weekly for 4 weeks,
every other week for 8 weeks, and then every 4 weeks. Treatment continues every 4 weeks in
the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive
escalating doses of TG4010 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 3 of 6 patients experience treatment related
grade 3 toxicity. If any patient experiences grade 4 toxicity, the prior dose level is
considered the MTD.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 months.
Primary Purpose: Treatment
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|