We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02555397
Recruitment Status : Active, not recruiting
First Posted : September 21, 2015
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Farzan Siddiqui, Henry Ford Health System

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Ad5-yCD/mutTKSR39rep-hIL12 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 16, 2019
Estimated Study Completion Date : February 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Single
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.
 Biological: Ad5-yCD/mutTKSR39rep-hIL12
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dose-dependent toxicity and maximum tolerated dose (MTD) of adenovirus [ Time Frame: 30 days from date of adenovirus injection (defined as day 1) ]

Secondary Outcome Measures :
  1. PSA response [ Time Frame: 2 years ]
  2. Freedom from biochemical/clinical failure (FFF) [ Time Frame: 2 years ]
  3. PSA doubling time (PSADT) [ Time Frame: 2 years ]
  4. Disease-specific and overall survival [ Time Frame: 5 years ]
  5. Quality of life (QOL) [ Time Frame: 2 years ]

Other Outcome Measures:
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555397


Locations
Layout table for location information
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 40202
Sponsors and Collaborators
Henry Ford Health System
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Farzan Siddiqui, Senior Staff Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02555397    
Other Study ID Numbers: Prostate Cancer (9829)
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farzan Siddiqui, Henry Ford Health System:
Prostate Cancer
Locally Recurrent
Gene Therapy
IL-12
Adenovirus
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases