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IRX-2 Regimen in CIN 3 or VIN 3
NCT03267680Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2017
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- University of Southern California
- Modality
- Cytokines & Interferons
- Drugs
- citoplurikin
- Conditions
- cervical intraepithelial neoplasia (CIN)vulvar intraepithelial neoplasia (VIN)
01
Overview
Phase 2, randomised, open-label trial in cervical intraepithelial neoplasia (CIN) and vulvar intraepithelial neoplasia (VIN) comparing Arm I (IRX-2) with Arm II (placebo) (2 arms). Primary endpoint: Pathologic Complete Response (CR) or Partial Response (PR) at 25 weeks. Started Nov 2017; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm I (IRX-2)
Cyclophosphamide + IRX-2 + Indomethacin + Zinc + Omeprazole
Arm II (placebo)
Cyclophosphamide + Placebo + Indomethacin + Zinc + Omeprazole
03
Who it enrols
Women with histologically confirmed squamous CIN 3 or VIN 3, adequate organ function, and no history of HIV, Hepatitis B/C, or autoimmune disease.
04
Endpoints
Primary
Pathologic Complete Response (CR) or Partial Response (PR)
Secondary
Incidence of Adverse Events
Clinical Complete Response (CR) or Partial Response (PR)
Frequency of Elimination of Human Papillomavirus (HPV)
Analysis of Immune Infiltrates
Immunophenotypic Analysis of Peripheral Blood Lymphocytes
Frequency of Serum Antibodies to HPV E6, E7 and L1 Proteins
RNA Expression Profiling of Immune-Inflammatory Markers
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