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Virus Therapy

Hiltonol (Poly-ICLC) for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by Ashutosh Kumar Tewari

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 36 months

Awards & highlights

Study Summary

This trial is comparing the effects of a drug called Poly-ICLC (Hiltonol®) versus no treatment on prostate cancer patients who are being monitored closely but not actively treated.

Who is the study for?

This trial is for men with prostate cancer who are being closely monitored (active surveillance) instead of immediate treatment. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Check my eligibility

What is being tested?

The study is testing Hiltonol® (Poly-ICLC), which will be given as shots into a muscle or directly into the tumor. It's a phase II pilot study to see if this treatment can benefit those on active surveillance compared to no treatment at all.See study design

What are the potential side effects?

While specific side effects for Poly-ICLC are not listed here, similar treatments may cause flu-like symptoms, injection site reactions, fatigue, and possibly mild fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects without Gleason group downgrade after treatment

Proportion of subjects without Gleason group upgrade after treatment

Secondary outcome measures

Number of subjects who experience adverse events per NCI-CTCAE 5.0

Number of subjects who receive prostate cancer treatment

Trial Design

2Treatment groups

Active Control

Group I: Hiltonol (Poly-ICLC)Active Control2 Interventions

Enrolled study subjects will receive paired intramuscular (IM) and intertumoral. (IT) injections of the drug Poly-ICLC (Hiltonol®) as follows: Paired 1.5 mg IM (week 1), 1 mg IT once (week 2), followed by paired 1.5 mg IM weekly from weeks 3-through10, and at weeks 14, 18, 22, 26, 30, 34, 38, 42 and 46 with a 4-week rest period between IM injections.

Group II: Control (Standard of Care)Active Control1 Intervention

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ashutosh Kumar TewariLead Sponsor

2 Previous Clinical Trials

40 Total Patients Enrolled

2 Trials studying Prostate Cancer

40 Patients Enrolled for Prostate Cancer

Oncovir, Inc.Industry Sponsor

23 Previous Clinical Trials

534 Total Patients Enrolled

2 Trials studying Prostate Cancer

27 Patients Enrolled for Prostate Cancer

Dimple Chakravarty, PhDStudy DirectorAssistant Professor

1 Previous Clinical Trials

15,240 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this clinical study?

"Indeed, as per details available on clinicaltrials.gov, this particular medical trial is actively seeking participants. Originally shared on January 16th, 2024, the latest update was made on March 27th of the same year. The goal is to enroll a total of 114 individuals at one designated site."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"As per clinicaltrials.gov, this investigation is currently enrolling volunteers. It was initially listed on 1/16/2024 and most recently revised on 3/27/2024."

Answered by AI

Has Hiltonol (Poly-ICLC) received official clearance from the FDA for usage?

"In this Phase 2 trial, the safety of Hiltonol (Poly-ICLC) is rated at 2 by our team at Power. This suggests there is existing data supporting its safety profile but not yet confirming its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

Ashutosh Kumar Tewari 2024. "Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06343077.

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