Status:
COMPLETED
Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer
Lead Sponsor:
Ashutosh Kumar Tewari
Collaborating Sponsors:
Oncovir, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 ...
Detailed Description
This is a pilot dose escalation study of IT/IM Poly-ICLC in patients with high risk clinically localized prostate cancer. The dose and frequency of IT injections will be increased in successive cohort...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Urine analysis positive for nitrites and leucocyte esterase. Such patients could be considered for the study after treatment and resolution of the infection.
- Active proctitis
- History of prostatic abscess
- Taking immunosuppressive medication including systemic corticosteroids
- Active hematologic malignancy
- No uncontrolled angina, congestive heart failure or MI within 6 months.
- Patients with history of HIV (if CD4+ T cell counts are ≥350 cells/µL on established ART therapy), Hepatitis B (with viral load below limits of quantification) or Hepatitis C (who have completed a curative therapy and have a viral load below the limit of quantification) are eligible for this study.
- No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy.
- Adequate end organ function as determined by the following laboratory values:
- White blood cell count (WBC) \> 2.5 k/mm3
- Absolute neutrophil count (ANC) \> 1.5 k/mm3
- Hemoglobin (Hgb) \> 8.0 g/dL
- Platelets \> 100 k/mm3
- Calculated creatinine clearance of \> 60 cc/min using the Cockcroft-Gault formula:
- Males: (140 - Age in years) × Actual Body Weight in kg 72 × Serum Creatinine (mg/dL)
- Bilirubin \< 2.0 x ULN
- Aspartate aminotransferase (AST) \< 2.5 x ULN
- Alanine aminotransferase (ALT) \< 2.5 x ULN 18) Able to speak, read and write in English.
Exclusion
Key Trial Info
Start Date :
June 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03262103
Start Date
June 16 2017
End Date
May 6 2022
Last Update
September 10 2022
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029