Back to resultsTNFerade Biologic to Treat Locally Advanced Prostate Cancer
Primary Purpose
Locally Advanced Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TNFerade™ Biologic
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Prostate Cancer focused on measuring Prostate, TNFerade Biologic
Eligibility Criteria
Inclusion Criteria
- Histological documented high-risk localized prostate cancer defined by clinical stage >=T3 or Gleason score ≥8.
- Lack of distant metastases (including bone, liver, or extrapelvic lymph node metastases) on standard CT and bone scanning. Patients with suspected or histologically confirmed pelvic lymph node metastases are eligible.
Normal organ function defined by:
- Hgb > 10 mg/dl (may be transfused or on erythropoietin);
- Platelets > 100,000/l;
- Absolute neutrophil count > 1500/l.
- Bilirubin < 1.5 mg/dl.
- AST and ALT < 1.5X upper limit of normal.
- Written signed informed consent.
Exclusion Criteria
- Absolute or relative contraindication to prostate radiotherapy including but not limited to prior pelvic radiotherapy, active infectious or inflammatory colitis, and inability to lay supine for daily radiation treatments.
- Requirement for ongoing antithrombotic treatment with coumadin or one of its derivatives, heparin or one of its derivatives, or thrombin inhibitors. Low dose aspirin for prevention of cardiovascular events is acceptable.
- Active vascular disease defined as a stroke, transient ischemic attack (TIA), myocardial infarction, or any vascular procedure performed for ischemic disease within the last 6 months.
- History of thrombosis (pulmonary embolism (PE) or deep vein thrombosis (DVT)) or known thrombophilia.
- Coagulopathy (INR>1.5, PTT ratio >1.5)
- Major surgery within the last 1 month (excludes minor superficial surgeries, biopsies, or minimally invasive approaches).
- Chemotherapy or experimental medications within 4 weeks of study entry.
- Chronic treatment for greater than 6 months with oral steroids at doses above 10 mg/day prednisolone (or equivalent).
- Clinical evidence of active infection of any type.
- HIV-positive patients receiving combination anti-retroviral therapy.
- Other significant concurrent medical or psychiatric illness that would limit compliance with study.
- Unwilling to use condoms or another barrier method of birth control for at least 8 weeks following the last dose of TNFerade™ Biologic and some form of birth control for at least one year. -
Sites / Locations
- University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
TNFerade™ Biologic + Radiation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01048151
First Posted
January 12, 2010
Last Updated
March 8, 2012
Sponsor
GenVec
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01048151
Brief Title
TNFerade Biologic to Treat Locally Advanced Prostate Cancer
Official Title
A PHASE I SAFETY AND TOLERABILITY TRIAL OF RADIOTHERAPY, ANDROGEN DEPRIVATION, AND INTRATUMORAL INJECTIONS OF AdGVEGR.TNF.11D (TNFeradeTM) FOR PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GenVec
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
While radiation therapy with androgen ablation (hormone reduction) is the standard method of treating locally advanced prostate cancer. New treatments are being combined with radiation therapy in an effort to further improve the cure rates.
This study proposes to combine an experimental drug, TNFerade™ Biologic, (also called AdGVEGR.TNF.11D or "TNFerade") at different dose (amounts) levels in combination with radiation.
TNFerade™ Biologic is a form of gene transfer therapy that when injected into the tumor has shown to increase the effect of radiation therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Prostate Cancer
Keywords
Prostate, TNFerade Biologic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
TNFerade™ Biologic + Radiation
Intervention Type
Biological
Intervention Name(s)
TNFerade™ Biologic
Other Intervention Name(s)
TNFerade™, AdGVEGR.TNF.11D
Intervention Description
AdGVEGR.TNF.11D
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Histological documented high-risk localized prostate cancer defined by clinical stage >=T3 or Gleason score ≥8.
Lack of distant metastases (including bone, liver, or extrapelvic lymph node metastases) on standard CT and bone scanning. Patients with suspected or histologically confirmed pelvic lymph node metastases are eligible.
Normal organ function defined by:
Hgb > 10 mg/dl (may be transfused or on erythropoietin);
Platelets > 100,000/l;
Absolute neutrophil count > 1500/l.
Bilirubin < 1.5 mg/dl.
AST and ALT < 1.5X upper limit of normal.
Written signed informed consent.
Exclusion Criteria
Absolute or relative contraindication to prostate radiotherapy including but not limited to prior pelvic radiotherapy, active infectious or inflammatory colitis, and inability to lay supine for daily radiation treatments.
Requirement for ongoing antithrombotic treatment with coumadin or one of its derivatives, heparin or one of its derivatives, or thrombin inhibitors. Low dose aspirin for prevention of cardiovascular events is acceptable.
Active vascular disease defined as a stroke, transient ischemic attack (TIA), myocardial infarction, or any vascular procedure performed for ischemic disease within the last 6 months.
History of thrombosis (pulmonary embolism (PE) or deep vein thrombosis (DVT)) or known thrombophilia.
Coagulopathy (INR>1.5, PTT ratio >1.5)
Major surgery within the last 1 month (excludes minor superficial surgeries, biopsies, or minimally invasive approaches).
Chemotherapy or experimental medications within 4 weeks of study entry.
Chronic treatment for greater than 6 months with oral steroids at doses above 10 mg/day prednisolone (or equivalent).
Clinical evidence of active infection of any type.
HIV-positive patients receiving combination anti-retroviral therapy.
Other significant concurrent medical or psychiatric illness that would limit compliance with study.
Unwilling to use condoms or another barrier method of birth control for at least 8 weeks following the last dose of TNFerade™ Biologic and some form of birth control for at least one year. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Manchen
Phone
773-702-4135
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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TNFerade Biologic to Treat Locally Advanced Prostate Cancer
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