An International, Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate Whether TroVax, Added to First-line Standard of Care Therapy, Prolongs the Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.
This is an international, randomised, double blind, placebo controlled, parallel group study
to investigate whether a minimum of three doses of TroVax® added to first-line standard of
care therapy, prolongs the survival of patients with locally advanced or metastatic renal
clear cell adenocarcinoma.
The primary endpoint is survival. The study is designed to be pragmatic, limiting additional
study related investigations to a minimum. Protocol mandated scans and X-rays are limited to
two time points (baseline and week 26) to permit comparison of the percentage of patients
with progressive disease at 6 months as a secondary efficacy endpoint. Six months was
selected based on review of published literature indicating that progressive disease was
commonly observed by 26 weeks in patients with renal cancer. Endpoints such as tumour
response by RECIST are considered of secondary importance to survival and will be determined
by radiological examinations ordered at the discretion of the investigator based on the
clinical status of the patient and will be based the interpretation of the patient's
care-team (investigator and local radiologist).
After signing the study informed consent form and meeting the baseline enrolment criteria
patients will be assigned by the investigator (their physician) to one of the following
defined first-line standard of care regimens based on what is best for the patient and
consistent with local practice:
1. subcutaneous low dose IL-2
2. interferon-α (excluding pegylated IFNα)
3. sunitinib
TroVax® is administered at a dose of 1E9TCID50/ml in 1ml by injection into the deltoid
muscle of the upper arm at regular intervals up to 8 weeks apart up to a maximum of 13
doses.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
overall survival
18 months
No
United States: Food and Drug Administration
TV3/001/06
NCT00397345
September 2006
December 2009
Name | Location |
---|---|
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Scripps Cancer Center | La Jolla, California 92037 |
Augusta Oncology Associates | Augusta, Georgia 30901 |
Broward Oncology Associates | Ft. Lauderdale, Florida 33308 |
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
Columbia Presbyterian Medical Center | New York, New York 10032 |
The Methodist Hospital | Houston, Texas 77030 |
Sharp Health Care | San Diego, California 92123 |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
AZ Cancer Center | Tucson, Arizona 85724 |
Little Rock Hematology / Oncology Associates, P.A. | Little Rock, Arkansas 72205 |
The Angeles Clinic and Reseach Institute | LA, California 90025 |
La Jolla, CA | La Jolla, California 92093 |
1300 N. Vermont Ave | Los Angeles, California 90027 |
UCLA Urology/Oncology | Los Angeles, California 90095 |
UCHSC | Aurora, Colorado 80045 |
Washington Cancer Center | Washington, District of Columbia 20010 |
SCORE Physician Alliance | Saint Petersburg, Florida 33709 |
SMO-USA Inc. | Canton, Georgia 301115 |
North Idaho Cancer Centre | Coeur D'Alene, Idaho 83814 |
Patricia A. Joyce Cancer Institute | Olympia Fields, Illinois 60461 |
Edward H Kaplan and Associates | Skokie, Illinois 60076 |
St Francis Hospital | Indianapolis, Indiana 46107 |
Cancer Care Centre of Indiana | New Albany, Indiana 47150 |
Henry Ford Health System / Josephine Ford Cancer Center | Detroit, Michigan 48202 |
University Minnesota Fairview Medical Center | Minneapolis, Minnesota 55455 |
Haematology and Oncology Associates at Bridgeport | Tupelo, Mississippi 38801 |
Charleston Hematology and Oncology Associates, | Billings, Montana 59101 |
Billings Clinical Research Center | Billings, Montana 59107 |
Freedman Urology | Las Vegas, Nevada 89109 |
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
The Cancer Center @ HUMC | Hackensack, New Jersey 07601 |
Pluta Cancer Centre | Rochester, New York 14623 |
Piedmont Hospital, Inc. | Canton, Ohio 30309 |
Riverside Cancer Centre | Columbus, Ohio 43214 |
Heamatology and Oncology Associates Inc. | Columbus, Ohio 43235 |
Flower Hospital/ Promedica Health System | Sylvania, Ohio 43560 |
Oregon Urology Institute | Springfield, Oregon 97477 |
Cancer Centre of the Carolinas | Greenville, South Carolina 29605 |
Urology Associates of South Texas | McAllen, Texas 78503 |
Cancer Outreach Associates PC | Abingdon, Virginia 24211 |
Madigan Army Medical Centre | Tacoma,, Washington 98109 |