REP0210: A single arm, preoperative, pilot study to evaluate the safety and biological effects of orally administered reparixin in early breast cancer patients who are candidates for surgery

Print this page

REP0210: A single arm, preoperative, pilot study to evaluate the safety and biological effects of orally administered reparixin in early breast cancer patients who are candidates for surgery

1) Evaluate the effects of orally administered reparixin on CSCs in the primary tumor andthe tumoral microenvironment:
A) CSCs will be measured in tissue samples by the following techniques: assessment of CD44/CD24 by flow cytometry or RT-PCR, ALDEFLUOR assay flow cytometry (or ALDH1 by RT-PCR) and by assessment of ALDH1, CD44/CD24 and epithelialmesenchymal markers (Snail, Twist, notch) by immunohistochemistry (IHC). CSCs will be defined as ALDEFLUOR positive (ALDH-1+) and/or CD44 high/CD24 low by flow cytometry or RT-PCR, with consistent results in IHC assays and by the detection of ALDH-1+ cells with or without epithelial-mesenchymal transition (EMT) transcription factor in IHC assays.
B) AKT, FAK, PTEN and CXCR1 levels will be measured in tissue samples by IHC.
C).Measure markers of inflammation (IL-1a, IL-6, IL-8, TNF-a, GM-CSF VEGF, b-
FGF and hsCRP) in plasma, leukocyte subsets (enumerate T (subsets), B, and NK/NKT) and study PMN biology in peripheral blood samples
D) Measure markers of angiogenesis (CD31 staining), autophagy (P62 and LC3 by
IHC), tumor infiltrating leukocytes (CD4, CD8, NK and macrophages), EpCAM and
EMT markers (CD326, CD45, Twist1, SNAIL1, SLUG, ZEB1, FOXC2, TG2, Akt2,
P13k and CK19) and tissue cellularity (residual disease characterization in tumor bed) in surgically resected tumor tissue samples.
2) Evaluate the safety of oral reparixin administered t.i.d. for 21 consecutive days.

Secondary Objective
1) Define the PK profile of orally administered reparixin.

Protocol Number041309
Principal InvestigatorDeborah Toppmeyer
PhasePilot
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedReparixin
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.