Clinical Trial Details

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Study ID MTG-REIC-PC003
Investigator
Christopher J Kane, MD,   University of California, San Diego
Brian J Miles, MD, FACS,   Baylor College of Medicine and Methodist Hospital
Title Study of a Recombinant Adenovirus to Treat Localized Prostate Cancer
Conditions Localized Prostate Cancer
Interventions Drug: Ad5-SGE-REIC/Dkk3
Phase Phase 1/Phase 2
Purpose The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in subjects with localized prostate cancer.
Eligibility Ages Eligible: 50 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
Inclusion Criteria: Key Inclusion Criteria: Subjects must meet all of the following criteria to be included: 1. Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate. 2. Subject with clinical stage T1 or T2 with Gleason score is between 6 and 7 (3+4 or 4+3). 3. Recent (≤ 3 months prior to study entry) negative bone scan and CT scan of abdomen/pelvis. 4. Life expectancy of at least 5 years. 5. Subjects should have adequate bone marrow function defined as an absolute peripheral granulocyte count ≥ 1,500 and platelet count of ≥ 100,000, adequate hepatic function with a bilirubin ≤ 1.5 mg/dl and SGPT < 4x the upper limits of normal, adequate renal function defined as serum creatinine ≤ 2.0 mg/dl 6. Subjects must have a coagulation profile (PT, PTT) not more than 2-times the upper limit of normal and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency). 7. Subject is willing to refrain from sexual activity or agrees to use a barrier contraceptive device (e.g. condom) for 8-weeks after treatment with Ad5-SGE-REIC/Dkk-3. 8. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded: 1. Hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational study drug within the past 4 weeks. 2. Unable to tolerate transrectal ultrasound. 3. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible. 4. Subjects who are HIV positive or have active hepatitis B or C infections are not eligible. 5. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids continuously for > 4 months [> 5 mg hydrocortisone/day] are ineligible. 6. As a result of medical review, physical examination, the Principal Investigator (or medically qualified nominee) considers the subject unfit for the study.
Study Location
UCSD Moores Cancer Center
San Diego, California, 92093
Contact Christopher J Kane, MD
858-822-6187
Information objtained from ClinicalTrials.gov, on 4/15/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01931046


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