Using Aspirin to Improve Immunological Features of Ovarian Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants that are greater than or equal to 18 years of age
For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French
Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2/3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.
Treatment naïve for this cancer diagnosis
Disqualifiers
Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment
History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant [serious or significant] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions).
History of hypertensive crisis and/ or uncontrolled HTN, systolic blood pressure > 150 mmHg; diastolic blood pressure > 90mmHg. Participants must have blood pressure < 150/90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study.
Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated
Trial design
Design model
Single group
Treatments tested in this trial
Aspirin 325mg
DrugParticipants 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.
Placebo
DrugParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Participants Randomized to AspirinExperimental treatment 1 intervention
Group B: Participants Randomized to PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 MonthsSecondary outcomes
1
Change in density of tumor COX1
Change in density of tumor COX1 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 Months2
Change in density of tumor COX2
Change in density of tumor COX2 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 Months3
Change in blood levels of IL-6
Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4
Time frame
Up to 84 days4
Change in blood levels of p-selectin
Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4
Time frame
Up to 84 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
United States Department of Defense
Collaborator
Sharp
Collaborator
Source ClinicalTrials.gov