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NCT03267680 · ClinicalTrials.gov registry record · Phase 2
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
A Phase 2 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03267680 is a Phase 2 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 10 participants.
The verdict
NCT03267680, a Phase 2 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Indomethacin
- DIETARY_SUPPLEMENT Multivitamin
- BIOLOGICAL IRX-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2024-03-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03267680
The ClinicalTrials.gov registry entry for NCT03267680 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03267680 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03267680 about?
NCT03267680 is a clinical study titled "IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3". 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-conta...
What is the current status of trial NCT03267680?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-11-08. Estimated completion is 2024-03-13.
What interventions are being tested in trial NCT03267680?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Indomethacin (DRUG), Multivitamin (DIETARY_SUPPLEMENT), IRX-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03267680?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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