Using Aspirin to Improve Immunological Features of Ovarian Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05080946
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspirin 325mg — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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

Key Dates

Start date
Nov 2, 2021
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants Randomized to Aspirin
    Participants randomized to this arm will receive 325mg daily dose aspirin
  • Placebo Comparator: Participants Randomized to Placebo
    Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)

Primary Outcome Measure

Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery [ Time Frame: Up to 5 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Tiffany Shiles
[email protected]
813-745-2948
Jing-Yi Chern, MD
[email protected]
813-745-7205
Jing-YI Chern, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Yukie Bean
[email protected]
503-418-4522
Alberta Barnes
[email protected]
Elizabeth Munro, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903
Marilyn Huang, MD
[email protected]
434-924-5197
Magnifique Irakoze
[email protected]
Marilyn Huang, MD (PRINCIPAL_INVESTIGATOR)
Inova Schar Cancer InstituteFairfaxVirginia22031
Eibhleann Cojocari
[email protected]
571-472-0246
Christina Annunziata, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FLOregon Health and Science University· Portland, ORUniversity of Virginia Comprehensive Cancer Center· Charlottesville, VAInova Schar Cancer Institute· Fairfax, VA

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