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.
  • Ad5-yCD/mutTKSR39rep-hIL12

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:Unknown status
Lead Sponsor:Henry Ford Health System

Trial Keywords

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

Last Updated

March 2, 2018