CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Intratumoral (IT) Poly ICLC 0.5 mg +3 morebiological
Likely dose
Intratumoral (IT) Poly ICLC 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03262103
NCT03262103Phase 1Completed
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Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy

Ashutosh Kumar Tewari·interventional·Posted Aug 25, 2017·Updated Sep 10, 2022

In Brief

A Phase 1 clinical trial evaluating Intratumoral (IT) Poly ICLC 0.5 mg, Intratumoral (IT) Poly ICLC 1.0 mg, and 2 other interventions for Prostate Cancer. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsOncovir, Inc.

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 25, 2017
Enrollment StartJun 16, 2017
Primary CompletionMay 6, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.9 years ago

Interventions

Intratumoral (IT) Poly ICLC 0.5 mgbiological

0.5 mg IT once/week (week 1)

Intratumoral (IT) Poly ICLC 1.0 mgbiological

1.0 mg IT once/week (week 1)

Intramuscular (IM) Poly ICLCbiological

1 mg IM twice weekly (weeks 3-6)

Radical Prostatectomyprocedure

as per standard care