NCT02555397
Completed
Phase 1
Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
Overview
- Phase
- Phase 1
- Intervention
- Ad5-yCD/mutTKSR39rep-hIL12
- Conditions
- Prostate Cancer
- Sponsor
- Henry Ford Health System
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Dose-dependent Toxicity
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Farzan Siddiqui
Senior Staff Physician
Henry Ford Health System
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 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
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:
Arms & Interventions
Single
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.
Intervention: Ad5-yCD/mutTKSR39rep-hIL12
Outcomes
Primary Outcomes
Dose-dependent Toxicity
Time Frame: 30 days from date of adenovirus injection (defined as day 1)
Secondary Outcomes
- Quality of Life (QOL)(2 years)
- PSA Doubling Time (PSADT)(2 years)
- Disease-specific and Overall Survival(5 years)
- PSA Response(2 years)
- Freedom From Biochemical/Clinical Failure (FFF)(2 years)
Study Sites (1)
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