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Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02555397
Recruitment Status : Active, not recruiting
First Posted : September 21, 2015
Last Update Posted : March 3, 2022
Information provided by (Responsible Party):
Farzan Siddiqui, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE September 17, 2015
First Posted Date  ICMJE September 21, 2015
Last Update Posted Date March 3, 2022
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date June 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
Dose-dependent toxicity and maximum tolerated dose (MTD) of adenovirus [ Time Frame: 30 days from date of adenovirus injection (defined as day 1) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
  • PSA response [ Time Frame: 2 years ]
  • Freedom from biochemical/clinical failure (FFF) [ Time Frame: 2 years ]
  • PSA doubling time (PSADT) [ Time Frame: 2 years ]
  • Disease-specific and overall survival [ Time Frame: 5 years ]
  • Quality of life (QOL) [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 17, 2015)
Association between the primary and secondary outcomes and immunological endpoints including serum IL-12 and IFN-y levels and NK cell cytolytic activity [ Time Frame: 3 months ]
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer
Official Title  ICMJE Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
Brief Summary The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Biological: Ad5-yCD/mutTKSR39rep-hIL12
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1
Study Arms  ICMJE Experimental: Single
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.
Intervention: Biological: Ad5-yCD/mutTKSR39rep-hIL12
Publications * Freytag SO, Barton KN, Zhang Y. Efficacy of oncolytic adenovirus expressing suicide genes and interleukin-12 in preclinical model of prostate cancer. Gene Ther. 2013 Dec;20(12):1131-9. doi: 10.1038/gt.2013.40. Epub 2013 Jul 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 17, 2015)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 14, 2023
Actual Primary Completion Date June 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy-proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy
  • Evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir
  • PSA < 100 ng/mL
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Negative lymph nodes as established by imaging (pelvic CT or pelvic MRI)
  • No evidence of metastatic disease, as evaluated by bone scan and CT scan of the abdomen and pelvis.
  • Subjects must have adequate baseline organ function as assessed by the the following laboratory values:
  • Adequate renal function with serum creatinine ≤ 1.5 mg/dL
  • Platelet count > 100,000/µL
  • Absolute neutrophil count > 1,000/µL
  • Hemoglobin > 10.0 g/dL
  • Bilirubin > 1.5 mg/dL
  • AST/SGOT and ALT/SGPT < 3.0 times upper limit of normal (ULN)
  • Men of child-producing potential must be willing to consent to use effective contraception for at least 3 months after the gene therapy
  • Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study

Exclusion Criteria:

  • PSA ≥ 100 ng/mL
  • Prostate volume > 100 cc
  • Pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but biopsy negative are allowed.
  • Evidence of M1 metastatic disease
  • Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects must be disease-free for > 5 years
  • Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
  • If the subject had prior androgen deprivation therapy (ADT), the subject exhibited biochemical failure while on ADT
  • Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowed; however, subjects must be > 2 years post-completion of chemotherapy at the time of registration. Subjects on Proscar therapy must stop to be eligible)
  • Major surgery planned within 3 months of registration
  • Severe, active co-morbidity defined as:
  • New York Health Association Class II or greater congestive heart failure or active ventricular arrhythmia requiring medication
  • Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within last 3 months or precluding study therapy at the time of registration
  • Acute infection
  • Previous history of liver disease including hepatitis
  • Immunosuppressive therapy including systemic corticosteroids (use of inhaled and topical corticosteroids is permitted)
  • Impaired immunity or susceptibility to serious viral infections
  • Allergy to any product used in the protocol. If the subject has an allergy to Ciproflaxin, another antibiotic can be substituted at the discretion of the treating physician
  • Serious medical or psychiatric illness or concomitant medication, which, in the judgement of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02555397
Other Study ID Numbers  ICMJE Prostate Cancer (9829)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Farzan Siddiqui, Henry Ford Health System
Original Responsible Party Hans Stricker, MD, Henry Ford Health System, Vice Chair - Urology
Current Study Sponsor  ICMJE Henry Ford Health System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henry Ford Health System
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP