Recruiting
Phase 1

TNFerade & Radiation

Sponsor:

GenVec

Code:

NCT01048151

Conditions

Locally Advanced Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

TNFerade™ Biologic

Study Details

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.

Conditions

Locally Advanced Prostate Cancer

Study ID

NCT01048151

Status verified date

Mar, 2012

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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. -

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single

TNFerade™ Biologic + Radiation

Interventions

TNFerade™ Biologic

AdGVEGR.TNF.11D

Central Contacts and Locations

Central contacts

Beth Manchen

773-702-4135

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

More Information

Sponsor

GenVec

Last update posted

Mar 12, 2012

Last verified

Mar, 2012

Keywords

  • Prostate
  • TNFerade Biologic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GenVec on 2012-03-12.