TroVax Renal Immunotherapy Survival Trial
- Conditions
- Clear Cell Renal Carcinoma
- Interventions
- Biological: PlaceboBiological: TrovaxBiological: Standard of care therapy
- Registration Number
- NCT00397345
- Lead Sponsor
- Oxford BioMedica
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 733
- Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements.
- Locally advanced or metastatic, histologically proven clear cell renal carcinoma.
- Primary tumour surgically removed (some residual advanced primary tumour may remain).
- At least four weeks post surgery or radiotherapy.
- First-line. No prior therapy for renal cancer except surgery or radiotherapy.
- Measurable disease.
- Aged 18 years or more.
- Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the investigator there is a >90% probability that the patient will survive >12 weeks if treated with the selected standard of care).
- Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).
- Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L.
- Serum creatinine ≤1.5 times the upper limit of normal.
- Bilirubin ≤ 2 times the upper limit of normal and an SGPT of ≤ 4 times the upper limit of normal.
- Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception (barrier or vasectomy) while they are being treated with TroVax®.
- No acute changes on 12-lead ECG.
- Ejection fraction documented as not less than 45% or no clinical suspicion that cardiac ejection fraction is less than 45%.(If clinical suspicion exists the ejection fraction should be measured according to local site procedures).
- Karnofsky performance status of ≥ 80%.
- Cerebral metastases. (Known from previous investigations or clinically detectable).
- Previous exposure to TroVax®.
- Serious infections within the 28 days prior to entry to the trial.
- Known to test positive for HIV or hepatitis B or C.
- Life threatening illness unrelated to cancer.
- History of allergic response to previous vaccinia vaccinations.
- Known allergy to egg proteins.
- Known hypersensitivity to neomycin.
- Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial.
- Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
- Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
- Oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
- Ongoing use of agents listed in locally approved prescribing information as causing immunosuppression.
- Prior history of organ transplantation.
- Pregnancy or lactation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Trovax Standard of care therapy - Placebo Standard of care therapy - Trovax Trovax -
- Primary Outcome Measures
Name Time Method overall survival 18 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (150)
AZ Cancer Center
🇺🇸Tucson, Arizona, United States
Little Rock Hematology / Oncology Associates, P.A.
🇺🇸Little Rock, Arkansas, United States
La Jolla, CA
🇺🇸La Jolla, California, United States
The Angeles Clinic and Reseach Institute
🇺🇸Los Angeles, California, United States
1300 N. Vermont Ave
🇺🇸Los Angeles, California, United States
UCLA Urology/Oncology
🇺🇸Los Angeles, California, United States
Sharp Health Care
🇺🇸San Diego, California, United States
Scripps Cancer Center
🇺🇸San Diego, California, United States
UCHSC
🇺🇸Aurora, Colorado, United States
Washington Cancer Center
🇺🇸Washington, District of Columbia, United States
SCORE Physician Alliance
🇺🇸Saint Petersburg, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
SMO-USA Inc.
🇺🇸Canton, Georgia, United States
North Idaho Cancer Centre
🇺🇸Coeur d'Alene, Idaho, United States
Patricia A. Joyce Cancer Institute
🇺🇸Olympia Fields, Illinois, United States
St Francis Hospital
🇺🇸Indianapolis, Indiana, United States
Cancer Care Centre of Indiana
🇺🇸New Albany, Indiana, United States
Charleston Hematology and Oncology Associates,
🇺🇸Billings, Montana, United States
Henry Ford Health System / Josephine Ford Cancer Center
🇺🇸Detroit, Michigan, United States
University Minnesota Fairview Medical Center
🇺🇸Minneapolis, Minnesota, United States
Billings Clinical Research Center
🇺🇸Billings, Montana, United States
Freedman Urology
🇺🇸Las Vegas, Nevada, United States
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
Pluta Cancer Centre
🇺🇸Rochester, New York, United States
Flower Hospital/ Promedica Health System
🇺🇸Sylvania, Ohio, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Cancer Centre of the Carolinas
🇺🇸Greenville, South Carolina, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Cancer Outreach Associates PC
🇺🇸Abingdon, Virginia, United States
Urology Associates of South Texas
🇺🇸McAllen, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Madigan Army Medical Centre
🇺🇸Tacoma, Washington, United States
CHU Besançon Hôpital Minjoz
🇫🇷Besancon, France
Centre Francois Baclesse
🇫🇷Caen, France
Centre François Baclesse-CLCC-Caen
🇫🇷Caen, France
Augusta Oncology Associates
🇺🇸Augusta, Georgia, United States
Piedmont Hospital, Inc.
🇺🇸Canton, Ohio, United States
Universitätsklinikum C.G. Carus TU Dresden
🇩🇪Dresden, Germany
Oncology department, Assaf Harofeh Medical Center
🇮🇱Be'er Ya'aqov, Zerifin, Israel
Oncology institute , Rambam /health Care Campus
🇮🇱Haifa, Israel
Oncology institute , The Chaim Sheba Medical center
🇮🇱Tel- Hashomer, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Oncology department Rabin Medical center
🇮🇱Petach Tikva, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept
🇵🇱Gdańsk, Poland
Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms
🇵🇱Krakow, Poland
Holycross Oncology Center in Kielce, Department of Urology
🇵🇱Kielce, Poland
Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic
🇵🇱Szczecin, Poland
Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology
🇵🇱Kraków, Poland
Lord's Transfiguration Independent Hospital Medical Academy Poznań
🇵🇱Poznan, Poland
Broward Oncology Associates
🇺🇸Fort Lauderdale, Florida, United States
Regional Specialistic Hospital in Wrocław, Department of Urology
🇵🇱Wrocław, Poland
Military Institute of Medicine, Department of Oncology
🇵🇱Warsaw,, Poland
Fundeni Clinical Institute - Urology Department
🇷🇴Bucharest,, Romania
Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System
🇵🇱Warsaw, Poland
Private Medical Centre
🇷🇴Arad,, Romania
Dinu Uromedica
🇷🇴Bucharest,, Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
🇷🇴Bucharest, Romania
E-URO Medical Center
🇷🇴Cluj-Napoca,, Romania
"I. Chiricuta" Institute of Oncology
🇷🇴Cluj-Napoca, Romania
Provita Center SRL
🇷🇴Constanţa, Romania
Sibiu Clinical County Hospital - Urology Clinic
🇷🇴Sibiu,, Romania
Republican Oncology Center" under the Ministry of Healthcare,
🇷🇺Petrozavodsk, Republic Of Karelia, Russian Federation
Leningrad Regional Oncological Center, Surgical Department #3
🇷🇺St Petersburg, Leningrad Region, Russian Federation
Oncomed SRL
🇷🇴Timisoara,, Romania
Edward H Kaplan and Associates
🇺🇸Skokie, Illinois, United States
The Cancer Center @ HUMC
🇺🇸Hackensack, New Jersey, United States
Riverside Cancer Centre
🇺🇸Columbus, Ohio, United States
Heamatology and Oncology Associates Inc.
🇺🇸Columbus, Ohio, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department
🇷🇺Kazan, Republic Of Tatarstan, Russian Federation
State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.
🇷🇺Arkhangelsk, Russian Federation
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,
🇷🇺Chelyabinsk, Russian Federation
Municipal Medical Institution: Oncological Center, Chemotherapy Department
🇷🇺Krasnodar, Russian Federation
Chelyabinsk Regional Oncological Center, Chemotherapy Department
🇷🇺Chelyabinsk, Russian Federation
State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology
🇷🇺Moscow, Russian Federation
Russian Research Center of Roentgenology & Radiology , Surgery Department
🇷🇺Moscow, Russian Federation
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy
🇷🇺Moscow, Russian Federation
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology
🇷🇺Moscow, Russian Federation
Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen
🇷🇺Moscow, Russian Federation
Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1
🇷🇺Moscow, Russian Federation
Non-State Medical Institution:Central Clinical Hospital
🇷🇺Moscow, Russian Federation
Murmansk Regional Oncological Center, Oncology Department #5
🇷🇺Murmansk, Russian Federation
Privolzhsky County Medical Center
🇷🇺Nizhny Novgorod, Russian Federation
State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)
🇷🇺Nizhny Novgorod, Russian Federation
Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology
🇷🇺Obninsk, Russian Federation
State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department
🇷🇺Omsk, Russian Federation
Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5
🇷🇺Orel, Russian Federation
Orenburg Regional Clinical Oncological Center, Chemotherapy Department
🇷🇺Orenburg, Russian Federation
Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department
🇷🇺Pyatigorsk, Russian Federation
Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology
🇷🇺Rostov-on-Don, Russian Federation
Regional Clinical Oncological Center, Surgery Department
🇷🇺Ryazan, Russian Federation
Samara Regional Oncology Center, Chemotherapy Department
🇷🇺Samara, Russian Federation
"Oncological Center", Department of Haematology and Chemotherapy
🇷🇺Sochi, Russian Federation
Municipal Multi-Speciality Hospital #2, Department of Urology
🇷🇺St Petersburg, Russian Federation
Municipal Hospital #26, Department Of Urology
🇷🇺St Petersburg, Russian Federation
"Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"
🇷🇺St Petersburg, Russian Federation
Department of Biotherapy and Bone Marrow Transplantation
🇷🇺St Petersburg, Russian Federation
St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department
🇷🇺St. Petersburg, Russian Federation
Department of Urology
🇷🇺St. Petersburg, Russian Federation
St. Petersburg State Pediatric Medical Academy
🇷🇺St. Petersburg, Russian Federation
State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology
🇷🇺Stavropol, Russian Federation
St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics
🇷🇺St.Petersburg, Russian Federation
State Medical Institution: Tambov Regional Oncological Center, Surgery Department
🇷🇺Tambov, Russian Federation
State Medical Institution of Yaroslavl Region
🇷🇺Yaroslavl, Russian Federation
Bashkir State Medical University, Urology Department
🇷🇺Ufa, Russian Federation
State Higher Educational Institution: Siberian State Medical University, Department of Urology
🇷🇺Tomsk, ,, Russian Federation
Hospital Severo Ochoa, Servicio de Oncologia - Primera planta
🇪🇸Leganes, Madrid, Spain
State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology
🇷🇺Yoshkar-Ola, Russian Federation
Hospital de Cruces
🇪🇸Barakaldo, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica
🇪🇸Barcelona, Spain
Hospital Marques de Valdecilla Consultas de Oncologia 1st planta
🇪🇸Santander, Spain
Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy
🇺🇦Chernivtsi, Ukraine
Haematology and Oncology Associates at Bridgeport
🇺🇸Tupelo, Mississippi, United States
Dnepropetrovsk State Medical Academy, Department of Urology
🇺🇦Dnepropetrovsk, Ukraine
Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department
🇺🇦Dnepropetrovsk, Ukraine
Donetsk Regional Antitumor Center, Urology Department
🇺🇦Donetsk, Ukraine
Ivano-Frankovsk State Medical University; Oncology Department
🇺🇦Ivano-Frankivs'k, Ukraine
Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department
🇺🇦Kharkov, Ukraine
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department
🇺🇦Kharkov, Ukraine
Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department
🇺🇦Kiev, Ukraine
Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department
🇺🇦Kiev, Ukraine
Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department
🇺🇦Krivoi Rog, Ukraine
Lugansk Regional Clinical Oncological Center, Urology Department
🇺🇦Lugansk, Ukraine
Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department
🇺🇦Lviv, Ukraine
Odessa State Medical University;
🇺🇦Odessa, Ukraine
Uzhgorod National University,
🇺🇦Uzhorod, Ukraine
Crimean Republican Clinical Oncological Center, Chemotherapy Department
🇺🇦Simferopol, Ukraine
Zaporozhye Medical Academy of Postgraduate Education, Oncology Department
🇺🇦Zaporozhye, Ukraine
Zaporozhye Medical Academy of Postgraduate Education, Urology Department
🇺🇦Zaporozhye, Ukraine
Mount Vernon Cancer Centre
🇬🇧Northwood, Middlesex, United Kingdom
Belfast City Hospital
🇬🇧Belfast, N. Ireland, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Bebington, Wirral, United Kingdom
The Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, United Kingdom
St Luke's Cancer Centre, Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
St. James University Hospital
🇬🇧Leeds, United Kingdom
Christie Hospital NHS Trust
🇬🇧Manchester, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
The Churchill Hospital
🇬🇧Oxford, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
The South West Wales Cancer Institute
🇬🇧Swansea, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
University of Nottingham
🇬🇧Nottingham, United Kingdom