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NCT03267680
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
Phase 2 trial testing Cyclophosphamide in Cervical Squamous Cell Carcinoma In Situ in 10 participants. Terminated before completion.
4 August 2023
Quick facts
| Lead sponsor | University of Southern California |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 8 November 2017 |
| Primary completion | 4 August 2023 |
| Estimated completion | 13 March 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Indomethacin (INDOMETHACIN) — full drug profile →
- IRX-2
- Laboratory Biomarker Analysis
- Multivitamin — full drug profile →
- Omeprazole (omeprazole) — full drug profile →
- Placebo
- Therapeutic Conventional Surgery
Conditions studied
- Cervical Squamous Cell Carcinoma In Situ — all drugs for Cervical Squamous Cell Carcinoma In Situ →
- Vulvar High Grade Squamous Intraepithelial Lesion — all drugs for Vulvar High Grade Squamous Intraepithelial Lesion →
Sponsor
University of Southern California
Who can join
25 and older, female only, with Cervical Squamous Cell Carcinoma In Situ or Vulvar High Grade Squamous Intraepithelial Lesion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic vaccines for high-risk HPV-associated diseases.
Chabeda A, Yanez RJR, Lamprecht R, Meyers AE, et al · · 2018 · cited 148× · PMID 29277575 · DOI 10.1016/j.pvr.2017.12.006 -
The integrated stress response in cancer progression: a force for plasticity and resistance.
Lines CL, McGrath MJ, Dorwart T, Conn CS. · · 2023 · cited 46× · PMID 37601686 · DOI 10.3389/fonc.2023.1206561 -
IRX-2 natural cytokine biologic for immunotherapy in patients with head and neck cancers.
Wolf GT, Moyer JS, Kaplan MJ, Newman JG, et al · · 2018 · cited 19× · PMID 29988729 · DOI 10.2147/ott.s165411 -
Increased immune infiltration and chemokine receptor expression in head and neck epithelial tumors after neoadjuvant immunotherapy with the IRX-2 regimen.
Berinstein NL, McNamara M, Nguyen A, Egan J, et al · · 2018 · cited 15× · PMID 29721379 · DOI 10.1080/2162402x.2017.1423173
Verify or expand the search:
- PubMed search for NCT03267680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Cervical Squamous Cell Carcinoma In Situ
Currently open trials in the same condition.
- NCT04712851 — Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03267680 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southern California
- Last refreshed: 13 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03267680.
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