Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

NCT03262103 | Completed Phase 1 FDA Drug

• 1 other identifier: GCO 15-2081
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate Cancer; Gleason 7-10; Immunotherapy; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicity level

  3+3 dose escalation rules to define a safe dose of preoperative intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) prior to radical prostatectomy

  Week 6

Secondary Outcomes (2)

• Number of adverse events

  Week 6

• Time to PSA progression

  up to Week 12

Study Arms (4)

Cohort 1

EXPERIMENTAL

Intratumoral (IT) Poly ICLC 0.5 mg IT once/week (week 1) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Biological: Intratumoral (IT) Poly ICLC 0.5 mg; Biological: Intramuscular (IM) Poly ICLC; Procedure: Radical Prostatectomy

Cohort 2

EXPERIMENTAL

Intratumoral (IT) Poly ICLC 0.5 mg IT once/week (week 1+2) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Biological: Intratumoral (IT) Poly ICLC 0.5 mg; Biological: Intramuscular (IM) Poly ICLC; Procedure: Radical Prostatectomy

Cohort 3

EXPERIMENTAL

Intratumoral (IT) Poly ICLC 1.0 mg IT once/week (week 1) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Biological: Intratumoral (IT) Poly ICLC 1.0 mg; Biological: Intramuscular (IM) Poly ICLC; Procedure: Radical Prostatectomy

Cohort 4

EXPERIMENTAL

Intratumoral (IT) Poly ICLC 1.0 mg IT once/week (week 1+2) Intramuscular (IM) Poly ICLC 1 mg IM twice weekly (weeks 3-6) Followed by Radical Prostatectomy at Week 10

Biological: Intratumoral (IT) Poly ICLC 1.0 mg; Biological: Intramuscular (IM) Poly ICLC; Procedure: Radical Prostatectomy

Interventions

Intratumoral (IT) Poly ICLC 0.5 mg BIOLOGICAL

0.5 mg IT once/week (week 1)

Cohort 1; Cohort 2

Intratumoral (IT) Poly ICLC 1.0 mg BIOLOGICAL

1.0 mg IT once/week (week 1)

Also known as: Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose

Cohort 3; Cohort 4

Intramuscular (IM) Poly ICLC BIOLOGICAL

1 mg IM twice weekly (weeks 3-6)

Also known as: Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Radical Prostatectomy PROCEDURE

as per standard care

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information.
• Age \> 18 years at the time of consent.
• ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual).
• Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis).
• Gleason 7 - 10, cT2a - cT3b adenocarcinoma of the prostate with plans for radical prostatectomy
• PSA ≥ 4 ng/ml
• Tumor visible on multiparametric MRI
• Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic
• Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy)
• Willing to undergo the intra-tumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol
• No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.) must be off treatment for at least 6 weeks prior to enrollment. Patients who have received prior LHRH agonist or antagonist therapy (leuprolide, goserelin acetate, etc.) are eligible provided serum testosterone is \> 50 mg/dl.
• No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate.
• No clinically significant infections as judged by the treating investigator.
• No characteristics suggesting a potential higher risk of infection with intraprostatic injections:
• Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study.

Sponsors & Collaborators

• Ashutosh Kumar Tewari: lead
• Oncovir, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

poly ICLC; Injections, Intramuscular

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ashutosh K. Tewari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Sujit S Nair, Ph.D.

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, System Chairman of the Department of Urology

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: June 16, 2017
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

US (1)