Clinical Trial: TroVax Renal Immunotherapy Survival Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief Summary: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.
Detailed Summary:
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:
- subcutaneous low dose IL-2
- interferon-α (excluding pegylated IFNα)
- sunitinib
TroVax® is administered at a dose of 1E9TCID50/ml in 1ml by injection into the deltoid muscle of th
Sponsor: Oxford BioMedica
Current Primary Outcome: overall survival [ Time Frame: 18 months ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Oxford BioMedica
Dates:
Date Received: November 8, 2006
Date Started: September 2006
Date Completion:
Last Updated: June 4, 2010
Last Verified: June 2010
