Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Participants randomized to this arm will receive 325mg daily dose aspirin

Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)

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.

Aspirin 325mg

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.

Placebo

Tiffany Shiles

Jing-Yi Chern, MD

Jing-YI Chern, MD

Marilyn Huang, MD

Magnifique Irakoze

Eibhleann Cojocari

Christina Annunziata, MD

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

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors

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.

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.

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.

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.

Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

Change in tumor burden be assessed using Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1)

United States Department of Defense

Sharp Clinical Services, Inc

H. Lee Moffitt Cancer Center and Research Institute

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Protective Agents

Participants will be given ASA 81 mg orally once daily for a total of 60 days

Participants will be given ASA 325 mg orally once daily for a total of 60 days.

Participants will be given a placebo orally once daily for a total of 60 days.

Aspirin 81 mg

Participants will be given ASA 325 mg orally once daily for a total of 60 days

Participants will be given placebo orally once daily for a total of 60 days

Placebo oral tablet

Douglas Grossman, MD

This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.

While melanoma risk is largely genetically determined, exposure to ultraviolet (UV) radiation in sunlight is the major environmental risk factor. Although sunscreen use can reduce melanoma risk 2-fold, its efficacy has been questioned, and most patients do not apply sunscreens properly.

This study will evaluate the downstream effects of aspirin (ASA) in human blood and skin moles (nevi) following oral ingestion. We will determine if chronic ingestion of ASA can modulate UV-sensitivity of the skin, UV-induced damage in nevi, and PGE2 levels in blood and nevi.

Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma

A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo

Baseline minimal erythemal dose (MED) measurements will will be compared to MED results at day 60. We will use the conventional definition of MED as the lowest UV dose resulting in erythema that completely fills the 8-mm irradiated site (homogeneous erythema).

Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.

Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.

Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60.

Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60.

Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60.

Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using Aspirin to Improve Immunological Features of Ovarian Tumors	NCT05080946	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Aspirin 325mg Placebo	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma	NCT04066725	Melanoma (Skin)	Aspirin 81 mg Aspirin 325mg Placebo oral ta...	18 Years -	University of Utah
Using Aspirin to Improve Immunological Features of Ovarian Tumors	NCT05080946	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Aspirin 325mg Placebo	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Using Aspirin to Improve Immunological Features of Ovarian Tumors	NCT05080946	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Aspirin 325mg Placebo	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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