Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin
by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in
patients with potentially platinum-sensitive recurrent Müllerian carcinomas.
2. Determine whether this treatment schedule is associated with:
1. increased levels of monocytes (>2-fold and absolute numbers 1000 cells/ml,) and of
LN-DR+ DC (CD11c+ and CD123+ subsets)
2. induction of priming and activation of MO/MA (monocytes/ macrophages), and
maturation of DC (dendritic cells).
3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal)
injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course.
4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in
patients with platinum-sensitive Müllerian carcinomas.
5. To begin an exploration of cell surface proteins on purified activated peripheral blood
and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.