Finding studies
Finding studies
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Lead
Roswell Park Cancer Institute
With
PRIMARY OBJECTIVES I. To evaluate the safety, tolerability, and feasibility of intraperitoneal (i.p.) administration of autologous tumor loaded DC vaccines (alpha-type-1 polarized dendritic cell \[alphaDC1\]) combined with intradermally administered aDC1 .(Safety \[Phase I aspect\]) II. To measure the intraperitoneal induction and persistence of aDCI induced sensitized cytotoxic T Cells (CTLs), which express natural killer (NK) cell-like features (nCTLs) and total CTLs following intraperitoneal administration of aDC1. (Local Immunologic Efficacy \[Phase II aspect\]) SECONDARY OBJECTIVES I. To study the T cell populations generated that correlates with higher anti-tumor responses. EXPLORATORY OBJECTIVES I. To evaluate the progression-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a phase I, dose-escalation study of nCTLs, followed by a phase IIa study. Patients receive the alpha-type-1 polarized dendritic cell vaccine intradermally (ID) 2 weeks before day 0, on day 0, and on day 28. Patients also receive nCTLs intraperitoneally (IP) over 15-30 minutes on day 0. In the absence of unacceptable side effects, patients may receive the alpha-type-1 polarized dendritic cell vaccine every 1-3 months at the discretion of the physician. After completion of study treatment, patients are followed up at 14 days, then at 6 and 12 months.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
