Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Indoleamine 2,3 dioxygenase 1 (IDO 1) is the major enzyme catabolising the Tryptophan outside the liver. It has been shown that its plays a important role in generating a immunosuppressive micro-environment in tumors. IDO expression has been shown by Hennequart et al. to be driven by Cyclooxygenase-2 (COX-2) expression. The investigator's team also shown that anti-COX2, celecoxib, can in a xenograft models of ovarian cancer decrease IDO1 expression and result in an infiltration of the tumor by T cells. The investigator proposed then to conduct a proof of concept study to evaluate the effect of pre-operative short administration of Celecoxib on IDO expression and Immune cells tumors infiltration, in patients with endometrial cancer. Indeed, this tumor type is well known to express frequently a high level of IDO.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Celecoxib

Criteria

Key Inclusion Criteria:

• Women > 18 years of age.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

• Adequate renal, hepatic and haematologic functions as defined by laboratory parameters.

• Agrees to undergo additional endometrial biopsies for scientific purposes.

Key Exclusion Criteria:

• Known hypersensitivity or intolerance to celecoxib

• Active, known or suspected autoimmune disease. Vitiligo, type I diabetes mellitus, residual hypothyroidism controlled by hormone substitution therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed.

• Positive hepatitis B or C, HIV, and pregnancy tests.

• Immunosuppressive treatment