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Intramuscular (IM) Poly ICLC for Prostate Cancer

Phase 1
Waitlist Available
Led By Ashutosh K. Tewari, MD
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 up to week 12
Awards & highlights

Study Summary

This trial will test whether injection of Poly-ICLC, a substance that stimulates the body's immune system, can help fight prostate cancer. The first aim is to determine the highest safe dose of Poly-ICLC, and the second is to assess its toxicity.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-Limiting Toxicity level
Secondary outcome measures
Number of adverse events
Time to PSA progression

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment3 Interventions
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
Group II: Cohort 3Experimental Treatment3 Interventions
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
Group III: Cohort 2Experimental Treatment3 Interventions
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
Group IV: Cohort 1Experimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboxymethylcellulose
FDA approved
Intratumoral (IT) Poly ICLC 0.5 mg
2017
Completed Phase 1
~20
Carboxymethylcellulose
FDA approved
Radical Prostatectomy
2005
Completed Phase 2
~4550

Find a Location

Who is running the clinical trial?

Ashutosh Kumar TewariLead Sponsor
2 Previous Clinical Trials
141 Total Patients Enrolled
1 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer
Oncovir, Inc.Industry Sponsor
23 Previous Clinical Trials
646 Total Patients Enrolled
1 Trials studying Prostate Cancer
14 Patients Enrolled for Prostate Cancer
Ashutosh K. Tewari, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
~2 spots leftby Jun 2025
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