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NCT03262103 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer
A Phase 1 study, sponsored by Ashutosh Kumar Tewari.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03262103 is a Phase 1 study that has completed, run by Ashutosh Kumar Tewari. The registered enrollment target is 13 participants.
The verdict
NCT03262103, a Phase 1 study, has completed, sponsored by Ashutosh Kumar Tewari.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic resonance imaging) ultrasound fusion technology into the prostate gland. Poly ICLC has been used to help the body in its fight against cancer. The first aim of the study is to determine the highest dose of a substance Poly-ICLC (Hiltonol®) that can be safely tolerated by the study participants. The second aim of the study is to find out the toxicity or side effects of poly-ICLC.
Interventions
- PROCEDURE Radical Prostatectomy
- BIOLOGICAL Intratumoral (IT) Poly ICLC 0.5 mg
- BIOLOGICAL Intratumoral (IT) Poly ICLC 1.0 mg
- BIOLOGICAL Intramuscular (IM) Poly ICLC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2022-05-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03262103
The ClinicalTrials.gov registry entry for NCT03262103 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ashutosh Kumar Tewari, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Radical Prostatectomy is the first listed.
NCT03262103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03262103 about?
NCT03262103 is a clinical study titled "Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer". The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic resonance imaging) ultrasound fusion ...
What is the current status of trial NCT03262103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-06-16. Estimated completion is 2022-05-06.
What interventions are being tested in trial NCT03262103?
The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Intratumoral (IT) Poly ICLC 0.5 mg (BIOLOGICAL), Intratumoral (IT) Poly ICLC 1.0 mg (BIOLOGICAL), Intramuscular (IM) Poly ICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT03262103?
This trial is sponsored by Ashutosh Kumar Tewari, which has 3 total clinical trials registered on ClinicalTrials.gov.
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