Status:
WITHDRAWN
Neoadjuvant Study of In-situ REIC/Dkk-3 in Prostate Cancer
Lead Sponsor:
Momotaro-Gene Inc.
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Prostate Cancer
Eligibility:
MALE
20-75 years
Phase:
PHASE1
Brief Summary
This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label, dose-escalation trial for prostate cancer patients with high risk of local recurrence after radical prostatectomy. Pat...
Detailed Description
This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label, dose-escalation trial for prostate cancer patients with high risk of local recurrence after radical prostatectomy. Pat...
Eligibility Criteria
Inclusion
- Male aged between 20 and 75 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate scheduled to undergo a radical prostatectomy.
- Patient with clinical stage T1c, T2 or T3 with Primary Gleason score of 4 \[total Gleason score of between 7 (4+3) and 10\] at time of assessment for this trial.
- Recent (≤ 3 months prior to study entry) negative bone scan and CT scan of abdomen/pelvis.
- Life expectancy of at least 10 years.
- In good general health, free from clinically significant illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests)
- Appropriate surgical candidate for radical prostatectomy and a performance status of ≤ 2 (Zubrod scale)
- Patients 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 total bilirubin ≤ 1.5 mg/dl and ALT \< 4x the upper limits of normal, adequate renal function defined as serum creatinine ≤ 2.0 mg/dl
- Body Mass Index ≥ 18 and ≤ 35 kg/m2
- Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
- Patient is willing to refrain from sexual activity or agrees to use a barrier contraceptive device (e.g. condom) after treatment with Ad-REIC/Dkk-3 and until the prostatectomy operation.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
Exclusion
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug within the past 4 weeks.
- Unable to tolerate transrectal ultrasound.
- Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death.
- Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders are not eligible.
- Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible (because of possible immune effects of these conditions).
- Patients with a clinical history of primary or secondary immunodeficiency, autoimmune disease or patients taking immunosuppressive drugs such as corticosteroids continuously for \> 4 months \[\> 5 mg hydrocortisone/day\] are ineligible. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have a decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- As a result of medical review, physical examination, the Principal Investigator (or medically qualified nominee) considers the subject unfit for the study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01197209
Start Date
September 1 2010
End Date
December 1 2010
Last Update
August 23 2013
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029