Locally Advanced Prostate CancerPhase 1NCT01048151
TNFerade Biologic to Treat Locally Advanced Prostate Cancer
A Phase 1 study testing TNFerade™ Biologic in people with Locally Advanced Prostate Cancer, run by GenVec at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Locally Advanced Prostate Cancer
- What is being tested?
- TNFerade™ Biologic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- Bilirubin < 1.5 mg/dl.
- AST and ALT < 1.5X upper limit of normal.
- Written signed informed consent.
Who cannot join
- 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).
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- 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. -
Trial locations and contacts
1 site in 1 country.
Beth Manchen contact
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
About this study
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
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.
- Conditions
- Locally Advanced Prostate Cancer
- Being tested
- TNFerade™ Biologic
- Keywords
- Prostate, TNFerade Biologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNFerade™ BiologicBiological
Also called TNFerade™, AdGVEGR.TNF.11D
AdGVEGR.TNF.11D
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | TNFerade™ Biologic + Radiation Receives: Biological: TNFerade™ Biologic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GenVec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048151
- Sponsor's protocol ID
- GV-001.012
- Status last verified
- Mar 2012
- First submitted
- 12 Jan 2010
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01048151
- Acronym / sponsor ID
- GV-001.012
- Conditions
- Locally Advanced Prostate Cancer
- Keywords
- Prostate, TNFerade Biologic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GenVecIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Biological: TNFerade™ BiologicTNFerade™ Biologic + Radiation |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Bilirubin < 1.5 mg/dl.
- AST and ALT < 1.5X upper limit of normal.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNFerade™ BiologicAlso: TNFerade™, AdGVEGR.TNF.11DAdGVEGR.TNF.11D | Biological | Single |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Manchen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNFerade™ Biologic in people with Locally Advanced Prostate Cancer, run by GenVec at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beth Manchen (773-702-4135), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.