Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance
Ashutosh Kumar Tewari
Summary
This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.
Description
114 prostate cancer participants on active surveillance will be randomized 2:1 into treatment group, A or control group B respectively. Enrolled group A study participants will receive standard of care (SOC) plus intratumoral (IT) and intramuscular (IM) injections of study drug Poly-ICLC (Hiltonol®) as follows: Preconditioning: week 1: Paired IM Poly-ICLC, 1.5 mg to reduce tumor induced suppression Immune Priming: week 2, intratumor poly-ICLC 1.0 mg once, Boosting: Wk. 3 - 10: Paired 1.5 mg IM poly-ICLC weekly Maintenance: Month 3-12, Paired IM Poly-ICLC once a month Control patients in g…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * 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). * • ISUP Grade 1(Gleason 3+3) and Grade 2 (Gleason 3+4) and Grade 1 (Gleason 3+3, with PSA≥10, or st…
Interventions
- DrugPoly-ICLC intramuscular (IM) injection
1.5 mg IM (week 1), 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.
- DrugPoly-ICLC, Intertumoral (IT) injection
1 mg IT once (week 2)
Location
- Icahn School of Medicine at Mount Sinai (ISMMS)New York, New York