Finding studies
Finding studies
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Lead
Michael Morse, MD
With
OBJECTIVES: * Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA. * Assess the CEA-specific immune response of patients treated with this regimen. * Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen. OUTLINE: This is a dose-escalation study. Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity. Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
