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Virus Therapy
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 12 months
Awards & highlights
No Placebo-Only Group
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.
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.
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 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of subjects without Gleason group downgrade after treatment
Proportion of subjects without Gleason group upgrade after treatment
Secondary study objectives
Number of subjects who experience adverse events per NCI-CTCAE 5.0
Number of subjects who receive prostate cancer treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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
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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
529 Total Patients Enrolled
2 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer
Sujit S Nair, PhDStudy DirectorAssistant Professor and Director of GU Immunotherapy Research
2 Previous Clinical Trials
15,267 Total Patients Enrolled
1 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer
Dimple Chakravarty, PhDStudy DirectorAssistant Professor
1 Previous Clinical Trials
15,240 Total Patients Enrolled