Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors
Summary
The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma
Arms & interventions
- DrugAspirin 325mg
Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.
- DrugPlacebo
Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.
Outcome measures
Primary
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.
Time frame: Up to 5 months
Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery
Change in intratumoral density of of M2 tumor-associated macrophages (CD163+ cells) will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)\*100 / density in the biopsy tissue sample.
Time frame: Up to 5 Months
Secondary
Change in density of tumor COX1
Time frame: Up to 5 Months
Change in density of tumor COX2
Time frame: Up to 5 Months
Change in blood levels of IL-6
Time frame: Up to 84 days
Change in blood levels of p-selectin
Time frame: Up to 84 days
Change in blood levels of CA 125
Time frame: Up to 84 days
Change in tumor burden as defined by RECIST 1.1
Time frame: Up to 5 Months
Eligibility criteria
Study locations (4)
Moffitt Cancer Center
Tampa, Florida, 33612
Oregon Health and Science University
Portland, Oregon, 97239
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
Inova Schar Cancer Institute
Fairfax, Virginia, 22031