drugset / Trial / NCT03267680
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
Phase 2
Terminated
10 enrolled
University of Southern California
Brooklyn ImmunoTherapeutics, LLC · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived biologic with multiple active cytokine components, may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.
Timeline
- Start
- 2017-11-08
- Primary completion
- 2023-08-04
- Completion
- 2024-03-13
Outcome
Outcome not reported
Stopped: “Lack of efficacy”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IRX-2 | Protein / enzyme biologic | — | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Indomethacin | Small molecule | — | Oral |
| Background | Omeprazole | Other / unclassified | — | Oral |