Recurrent Ovarian Carcinoma Clinical Trial
Official title:
Pilot Study of the Pre-Conditioning Effects of Anti-Macrophage Therapy Using PD 0360324 in Recurrent Platinum-Resistant Epithelial Ovarian Cancer
This phase II trial studies the side effects of PD 0360324 and cyclophosphamide and to see how well they work in treating patients with high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement. Immunotherapy with monoclonal antibodies, such as PD 0360324, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cyclophosphamide may stop the growth of disease by blocking the growth of new blood vessels necessary for tumor growth. Giving PD 0360324 and cyclophosphamide may work better in treating patients with high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer.
PRIMARY OBJECTIVES:
I. To establish the safety of anti-CSF1 monoclonal antibody PD-0360324 (PD 0360324) followed
by cyclophosphamide in patients with epithelial ovarian, fallopian tube, and primary
peritoneal cancers.
II. To examine the density of CD8+ T cells in tumor biopsies before and after PD 0360324.
SECONDARY OBJECTIVES:
I. To evaluate response rate and progression free survival associated with low dose oral
cyclophosphamide after PD 0360324 treatment.
II. To evaluate M-CSF concentrations before and after treatment with PD 0360324 and during
cyclophosphamide therapy.
TERTIARY OBJECTIVES:
I. To evaluate the immunologic effects of PD 0360324 on peripheral blood and ovarian cancer
tissue.
II. To explore the relationships between drug concentration and immunologic biomarkers and
response.
OUTLINE:
Patients receive anti-CSF1 monoclonal antibody PD 0360324 intravenously (IV) over 30 minutes
on days 1, 8, 15, and 22. Starting on day 43, patients receive cyclophosphamide orally (PO)
once daily (QD). Courses with cyclophosphamide repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 90 days.
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