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TNFerade Biologic to Treat Locally Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01048151
Recruitment Status : Unknown
Verified March 2012 by GenVec.
Recruitment status was:  Recruiting
First Posted : January 13, 2010
Last Update Posted : March 12, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
GenVec

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.


Condition or disease Intervention/treatment Phase
Locally Advanced Prostate Cancer Biological: TNFerade™ Biologic Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Single
TNFerade™ Biologic + Radiation
Biological: TNFerade™ Biologic
AdGVEGR.TNF.11D
Other Names:
  • TNFerade™
  • AdGVEGR.TNF.11D





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048151


Contacts
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Contact: Beth Manchen 773-702-4135

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
GenVec
National Institutes of Health (NIH)

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Responsible Party: Paul Fischer, PhD, CEO, GenVec
ClinicalTrials.gov Identifier: NCT01048151     History of Changes
Other Study ID Numbers: GV-001.012
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by GenVec:
Prostate
TNFerade Biologic

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases