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Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

NCT03262103 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-09-10

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

Intratumoral (IT) Poly ICLC 0.5 mg

0.5 mg IT once/week (week 1)

BIOLOGICAL

Intratumoral (IT) Poly ICLC 1.0 mg

1.0 mg IT once/week (week 1)

BIOLOGICAL

Intramuscular (IM) Poly ICLC

1 mg IM twice weekly (weeks 3-6)

PROCEDURE

Radical Prostatectomy

as per standard care

Sponsors & Collaborators

  • Oncovir, Inc.

    collaborator INDUSTRY

  • Ashutosh Kumar Tewari

    lead OTHER

Principal Investigators

  • Ashutosh K. Tewari, MD · Icahn School of Medicine at Mount Sinai

  • Sujit S Nair, Ph.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2022-05-06
Completion
2022-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262103 on ClinicalTrials.gov