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Using Aspirin to Improve Immunological Features of Ovarian Tumors

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ClinicalTrials.gov Identifier: NCT05080946
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : December 15, 2021
Sponsor:
Collaborators:
United States Department of Defense
Sharp Clinical Services, Inc
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief 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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Aspirin 325mg Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: Participants Randomized to Aspirin
Participants randomized to this arm will receive 325mg daily dose aspirin
Drug: Aspirin 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.

Placebo Comparator: Participants Randomized to Placebo
Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)
Drug: Placebo
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.




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

  2. Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery [ Time Frame: Up to 5 Months ]
    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.


Secondary Outcome Measures :
  1. Change in density of tumor COX1 [ Time Frame: Up to 5 Months ]
    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.

  2. Change in density of tumor COX2 [ Time Frame: Up to 5 Months ]
    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.

  3. Change in blood levels of IL-6 [ Time Frame: Up to 84 days ]
    Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

  4. Change in blood levels of p-selectin [ Time Frame: Up to 84 days ]
    Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

  5. Change in blood levels of CA 125 [ Time Frame: Up to 84 days ]
    Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

  6. Change in tumor burden as defined by RECIST 1.1 [ Time Frame: Up to 5 Months ]
    Change in tumor burden be assessed using Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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. All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.
  • Treatment naïve for this cancer diagnosis
  • Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +/- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. [Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.]
  • Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
  • Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available.
  • If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement
  • Willing and able to swallow pills without difficulty
  • Un-transfused platelet count > 100,000 cells/μL
  • Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log/diary)
  • Absolute neutrophil count > 1.5 x 109 cells/L
  • Hemoglobin > 9.0 g/dL, may use transfusions and the value can be post-transfusion
  • Estimated creatinine clearance of > 30 mL/min, calculated using the formula Cockcroft-Gault [(140-age) x Mass (kg)/(72 x creatinine mg/dL)] x 0.85 for female
  • No severe hepatic impairment defined as AST or ALT elevation < 2.5 x institutional ULN, unless liver metastasis is present < 5 x ULN

Exclusion Criteria:

  • 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
  • History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study
  • Uncontrolled erosive esophagitis requiring 2 or more treatments
  • Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer
  • Autoimmune disorder requiring systemic therapy
  • Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days.
  • Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy)
  • History of bariatric surgery
  • Currently pregnant at the Screening visit or planning on becoming pregnant during the study period
  • Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.
  • Metabolism CYP2C9, known G6PD deficient patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080946


Contacts
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Contact: Tiffany Shiles 813-745-2948 Tiffany.Shiles@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Tiffany Shiles    813-745-2948    Tiffany.Shiles@moffitt.org   
Contact: Jing-Yi Chern, MD    813-745-7205    Jing-Yi.Chern@moffitt.org   
Principal Investigator: Jing-YI Chern, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
United States Department of Defense
Sharp Clinical Services, Inc
Investigators
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Principal Investigator: Jing-Yi Chern, MD Moffitt Cancer Center
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT05080946    
Other Study ID Numbers: MCC-20870
E01775.1a ( Other Grant/Funding Number: DOD )
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics