Clinical Trials /

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

NCT02555397

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer
  • Official Title: Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy

Clinical Trial IDs

  • ORG STUDY ID: Prostate Cancer (9829)
  • NCT ID: NCT02555397

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Ad5-yCD/mutTKSR39rep-hIL12Single

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
SingleExperimentalSingle intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.

    Eligibility 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 nondes 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 illiness 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Dose-dependent toxicity and maximum tolerated dose (MTD) of adenovirus
    Time Frame:30 days from date of adenovirus injection (defined as day 1)
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:PSA response
    Time Frame:2 years
    Safety Issue:
    Description:
    Measure:Freedom from biochemical/clinical failure (FFF)
    Time Frame:2 years
    Safety Issue:
    Description:
    Measure:PSA doubling time (PSADT)
    Time Frame:2 years
    Safety Issue:
    Description:
    Measure:Disease-specific and overall survival
    Time Frame:5 years
    Safety Issue:
    Description:
    Measure:Quality of life (QOL)
    Time Frame:2 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Henry Ford Health System

    Trial Keywords

    • Prostate Cancer
    • Locally Recurrent
    • Gene Therapy
    • IL-12
    • Adenovirus

    Last Updated

    August 17, 2016