Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02948101

PD 0360324 and Cyclophosphamide in Treating Patients With Recurrent High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Pilot Study of the Pre-Conditioning Effects of Anti-Macrophage Therapy Using PD 0360324 in Recurrent Platinum-Resistant Epithelial Ovarian Cancer

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAnti-CSF1 Monoclonal Antibody PD-0360324Given IV
DRUGCyclophosphamideGiven PO
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2018-12-31
Primary completion
2019-02-06
Completion
2019-02-06
First posted
2016-10-28
Last updated
2019-03-12

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02948101. Inclusion in this directory is not an endorsement.