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Sponsored by: |
Oxford BioMedica |
Information provided by: | Oxford BioMedica |
ClinicalTrials.gov Identifier: | NCT00397345 |
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.
Condition | Intervention | Phase |
Clear Cell Renal Carcinoma |
Biological: Trovax |
Phase III |
MedlinePlus related topics: | Cancer Kidney Cancer |
Drug Information available for: | 5T4 cancer vaccine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma. |
Estimated Enrollment: | 700 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: Trovax
1ml IM injection 2-8 weeks apart.
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2: Placebo Comparator |
Biological: Trovax
1ml IM injection 2-8 weeks apart.
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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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 153 Study Locations |
Oxford BioMedica |
Responsible Party: | Oxford BioMedica ( Dr Mike McDonald ) |
Study ID Numbers: | TV3/001/06 |
First Received: | November 8, 2006 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00397345 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Romania: National Medicines Agency |
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