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Date posted 2007-04-11 16:25
Subject TroVax Renal Immunotherapy Survival Trial 
Opinion Strong BUY
Votes for this Posting Voted UP 3 times.
Message
As some of you seem lost here is some thing I found that might help yoy while away the time sorry its a bit long,but you to can join at a hospital near you
TroVax Renal Immunotherapy Survival Trial

This study is currently recruiting patients.
Verified by Oxford BioMedica March 2007

Sponsored by: Oxford BioMedica
Information provided by: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT00397345


Purpose

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
Vaccine: Trovax
Phase III


MedlinePlus related topics: Cancer; Kidney Cancer
Genetics Home Reference related topics: Cancer; Kidney Cancer

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

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.

Further study details as provided by Oxford BioMedica:

Expected Total Enrollment: 700
Study start: September 2006


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 the upper arm at regular intervals up to 8 weeks apart up to a maximum of 13 doses.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

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%.
Exclusion Criteria:

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.
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00397345

Sarah Eastty +44 1865783000 s.eastty@oxfordbiomedica.co.uk


United States, Arizona
AZ Cancer Center, Tucson, Arizona, 85724, United States; Not yet recruiting
Loraine Ruezitis 520-626-1183 lruezitis@azcc.arizona.edu
Scott Ebbinghaus, Principal Investigator


United States, Colorado
UCHSC, Aurora, Colorado, 80045, United States; Not yet recruiting
Melissa Gonzalez 720-848-0050 Harry.Drabkin@uchsc.edu
303-724-3849
Harry Drabkin, Principal Investigator


United States, District of Columbia
Washington Cancer Center, Washington, District of Columbia, 20010, United States; Not yet recruiting
Becky Montalvo 202-877-8787 bkm2@medstar.net
202-877-2843
David Perry, Principal Investigator


United States, Florida
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, 33612, United States; Not yet recruiting
Helen Taylor 813-745-8400 Ext. 3982 "Fishmamn@moffitt.usf.edu
813-745-8343
Mayer Fishman, Principal Investigator


University of Miami, Miami, Florida, 33136, United States; Not yet recruiting
Jose Quesada 305-243-8807 jquesada2@med.miami.edu
305-243-3295
D S Ernst, Principal Investigator


United States, Georgia
Peachtree Hem Onc Consultants (Polly Searcy, SC), Atlanta, Georgia, 30309, United States; Not yet recruiting
Polly Searcy 404-350-9853 chenderson@phoc.com
research@phoc.com
Charles Henderson, Principal Investigator


SMO-USA Inc., Canton, Georgia, 301115, United States; Recruiting
Carrie Smith 770-704-8215 rich@smo-usa.com
Nashat Gabrail, Principal Investigator


United States, Indiana
St Francis Hospital, Indianapolis, Indiana, 46107, United States; Not yet recruiting
Cathy Spears 317-782-7819 cathy.spears@ssfhs.org
Khuda Khan, Principal Investigator


United States, Michigan
Karamanos Cancer Institute, Detroit, Michigan, 48201, United States; Not yet recruiting
Brenda Dickon 313-576-9372 heathe@karmanos.org
313-576-8715
Elisabeth Heath, Principal Investigator


United States, Minnesota
University Minnesota Fairview Medical Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Katie Mellskog, RN 612-624-6610 dudek002@umn.edu
Arkadiusz Dudek, Principal Investigator


United States, New Jersey
The Cancer Center @ HUMC, Hackensack, New Jersey, 07601, United States; Not yet recruiting
Kevin Barga 201-996-5900 kbarga@humed.com
Robert Alter, Principal Investigator


United States, New York
Columbia Presbyterian Medical Center, New York, New York, 10032, United States; Not yet recruiting
Gail DeRaffele, RN 212-342-0232 gd2023@columbia.edu
Josie Mitcham 212-342-0233 jm2124@columbia.edu
Howard L Kaufman, MD, Principal Investigator


United States, Oklahoma
Urology Specialists of Oklahoma, Tulsa, Oklahoma, 74146, United States; Not yet recruiting
June Jordon, LPN, CRA 918-392-2291 jjordan@urologicspecialists.com
John Forrest, Principal Investigator


United States, Texas
The Methodist Hospital, Houston, Texas, 77030, United States; Recruiting
Joan Hernandez 713-441-7943 jhmcclain@tmh.tmc.edu.
Robert J Amato, MD, Principal Investigator


United States, Washington
Virginia Mason Medical Center, Seattle, Washington, 98101, United States; Not yet recruiting
Layle Smith 206-583-6559 Ext. 66040 layle.smith@vmmc.org
206-223-6193
Jacueline Vuky, Principal Investigator


France
Centre François Baclesse-CLCC-Caen, Caen, 14076, France; Not yet recruiting
Florence Joly 02 31 45 51 97
Emmanuel Sevin, Principal Investigator
Florence Joly, Sub-Investigator


Insitut Curie, Paris, 75248, France; Not yet recruiting
Laurence Escalup 01 44 324 672
Thierry Dorval, Principal Investigator


CHU Besançon Hôpital Minjoz, Besancon, 25030, France; Not yet recruiting
Mrs Essert 03 81 66 87 06
Ulrich Stein, Principal Investigator


Centre Jean Perrin, Clermont-Ferrand, 63 011, France; Not yet recruiting
Frederic Huee +33 4 73 27 80 80
Jacques-Olivier Bay, Principal Investigator


Centre René Gauducheau, St Herlain, 44805, France; Not yet recruiting
Philippe Palardy 0033 2 40 67 99 76
Frederic Rolland, Principal Investigator


France, Cedex
Centre Val d'Aurelle, Montpellier, Cedex, 5, France; Not yet recruiting
Laurence Culine 0033 4 67 61 31 00 (SC & Phar)
Stephane Culine, Principal Investigator


Israel
Meir Medical Center, Kfar Saba, 44281, Israel; Not yet recruiting
Sigalit 09-7472101, 052-2358976
Avivit Neuman, Principal Investigator


Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel; Not yet recruiting
Naomi 03-6974053
Ben Yosef, Principal Investigator


Oncology institute , Rambam /health Care Campus, Haifa, 31096, Israel; Recruiting
Esti 04-8543170
Georgeta Fried, Principal Investigator


Oncology department Rabin Medical center, Petach Tikva, 49100, Israel; Not yet recruiting
Stemmer Salomon 03-9231437
Stemmer Salomon, Principal Investigator


Oncology institute , The Chaim Sheba Medical center, Tel- Hashomer, 52621, Israel; Recruiting
Ety 03-5305347/ 5302335 ;
Rony Weitzen, Principal Investigator


Israel, Zerifin
Oncology department, Assaf Harofeh Medical Center, P.O.Beer Yaacov, Zerifin, 70300, Israel; Not yet recruiting
Secretary +08-9779715
Avishay Sella, Principal Investigator


Poland
Holycross Oncology Center in Kielce, Department of Urology, Kielce, 25-734, Poland; Not yet recruiting
Zyta Widanka, MBA, Msci +48 41 367 47 74
+ 48 41 367 47 75 piotr.chlosta@pharmanet.com.pl
Piotr Chłosta, Dr., Principal Investigator


Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System, Warsaw, 02-781, Poland; Not yet recruiting
+48 (22) 546 23 31 wiechnop@o2.pl
Tomasz Demkov, Principal Investigator
Pawel Wiechno, Dr, Sub-Investigator


IIndependent Public Clinical Hospital #1- Academic Clinical Center of Medical Academy in Gdańsk, Oncology and Radiotherapy Department, Gdańsk, 80-952, Poland; Not yet recruiting
+48 58 349 22 70 onkol@amg.gda.pl
jjassem@amg.gda.pl
Jacek Jassem, Principal Investigator
Agnieszka Pliszka, Sub-Investigator


Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology, Kraków, 31-501, Poland; Not yet recruiting
+48 12 424 76 80 japa46@op.pl
Janusz Pawlega, Prof., Principal Investigator


Maria Sklodowska-Curie Memorial Institute, Oncology Center in Kraków, Clinic of Systemic and Generalized Neoplasms, Krakow, 31-115, Poland; Not yet recruiting
+48 12 423 10 34
Janusz Rolski, Principal Investigator
Beata Wiczynska, Sub-Investigator


Independent Public Clinical Hospital #2 – Pomeranian Medical Academy in Szczecin, Urology Clinic, Szczecin, 70-111, Poland; Not yet recruiting
+48 91 466 11 01 martwist@post.pl
Marcin Slojewski, Sub-Investigator
Andrzej Sikorski, Prof, Principal Investigator


Regional Specialistic Hospital in Wrocław, Department of Urology, Wrocław, 51-124, Poland; Not yet recruiting
+48 71 327 03 15
+48 501 224 012 korabl@interia.pl
Marek Fiutowski, Sub-Investigator
Jerzy Sokolowski, Dr., Principal Investigator


Military Institute of Medicine, Department of Oncology, Warsaw,, 00-909, Poland; Not yet recruiting
+48 22 681 72 35 cszczylik@wim.mil.pl
+48 22 681 66 75 agruziel@wim.mil.pl
Agnieszka Gruziel, Sub-Investigator
Cezary Szczylik, Prof., Principal Investigator


Lord’s Transfiguration Independent Public Clinical Hospital # 1 of Medical Academy in Poznań, Department of Chemotherapy, Poznan, 61-848, Poland; Not yet recruiting
+48 61 854 90 38 piotr.tomczak@oncology.am.pl
Piotr Tomczak, Dr., Principal Investigator


Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic, Bucharest, Romania; Recruiting
Viorel Jinga, MD 0722 743 263 vioreljinga@yahoo.com
Stelian Persu, MD, Principal Investigator


Provita Center SRL, Constanţa, 900635, Romania; Recruiting
Laurentiu Babu 40 241 517 274 laur_babu@yahoo.com
Laurentiu Babu, Dr., Principal Investigator
Cristina Dumbrava, Dr., Sub-Investigator


"I. Chiricuta" Institute of Oncology, Cluj-Napoca, 400015,, Romania; Recruiting
Tudor Ciuleanu 40 264 598 361 tudor_ec2002@yahoo.fr
Tudor Ciuleanu, Dr, Principal Investigator
Dana Iancu, Dr., Sub-Investigator


E-URO Medical Center, Cluj-Napoca,, 400420, Romania; Not yet recruiting
Ioan Coman, Assoc. Prof. 40 264 406 718 jcoman@yahoo.com
Ioan Coman, Assoc. Prof., Principal Investigator
Vasile Stanca, Dr., Sub-Investigator


Dinu Uromedica, Bucharest,, 041345, Romania; Recruiting
Marius Dinu, Dr. 40 21 332 03 56 dinu.marius@xnet.ro
Marius Dinu, Dr., Principal Investigator
Radu Croituru, Dr., Sub-Investigator


Sibiu Clinical County Hospital - Urology Clinic, Sibiu,, 550245, Romania; Recruiting
Nicolae Grigore, Assoc. Prof. 40 269 215 050 nicolaegrigore2000@yahoo.com
Nicolae Grigore, Assoc. Prof., Principal Investigator
Adrian Hasegan, Dr., Sub-Investigator


Fundeni Clinical Institute - Urology Department, Bucharest,, 022328, Romania; Recruiting
Mihai Harza, Dr. 40 21 311 46 45 txfundeni@easynet.ro
Mihai Harza, Dr., Principal Investigator
Bogdan Serbanescu, Dr., Sub-Investigator
Codrut Pave, Dr., Sub-Investigator
Alexandru Iordache, Dr., Sub-Investigator


Private Medical Centre, Arad,, 310175, Romania; Not yet recruiting
Ioan Ioiart, Dr. 40 257 255 255 icosmin@rdslink.ro
Ioan Ioiart, Dr., Principal Investigator


Oncomed SRL, Timisoara,, 300239, Romania; Recruiting
Anca Niculescu, Dr. 40 256 495 403
Anca Niculescu, Dr., Principal Investigator
Daniela Sarbu, Dr., Sub-Investigator


"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic, Bucharest,, 050659,, Romania; Recruiting
Stelian Persu, Prof. 40 21 410 69 10 cpersu@pcnet.ro
Stelian Persu, Prof., Principal Investigator
Viorel Jinga, Dr., Sub-Investigator
Gheorghita Caraivan, Dr., Sub-Investigator


Russian Federation
Federal State Institution: Privolzhsky County Medical Center under the Federal Agency for Healthcare and Social Development, Urology Department #2, Nizhny Novgorod, 603001, Russian Federation; Recruiting
Anna Valerievna Alyasova, Dr. 7 8312 33 02 47 alyasovaav68@mail.ru'
Tatiana Viktorovna Rumiantseva 7 8312 334494 gl_vrach@mts-nn.ru
Anna V Alyasova, Dr., Principal Investigator
Tatiana V Rumiantseva, Sub-Investigator
Vagif A Atduev, Sub-Investigator
Mikhail V Khazov, Chief Physician, Sub-Investigator


State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7., Arkhangelsk, 163045, Russian Federation; Recruiting
Alexander V Arkhipov, Dr. 7 8182 27 52 69 aokod@rambler.ru
Mikhail A Sumarokov 78182 27 56 37
Alexander V Arkhipov, Dr., Principal Investigator
Mikhail A Sumarokov, Sub-Investigator


Non-State Medical Institution:Central Clinical Hospital #2 n.a. N.A. Semashko under OAO Russian Railways, Chemotherapy Department, Moscow, 129128, Russian Federation; Recruiting
Mikhail Y Biakhov, Prof. 7 495 187 74 83 biakhov@online.ru
Benevolenskaya N Olegovna 7 495 187 74 83
Benevolenskaya N Olegovna, Sub-Investigator
Mikhail Y Biakhov, Prof., Principal Investigator


State Medical Institution of Yaroslavl Region "Regional Clinical Oncological Hospital", Chemotherapy Department, Yaroslavl, 150054, Russian Federation; Recruiting
Sergei V Cheporov, Dr. 7 4852 74 42 10 sergey.cheporov@rambler.ru
Sergei V Cheporov, Dr., Principal Investigator


Municipal Medical Institution: Oncological Center, Chemotherapy Department, Krasnodar, 350040, Russian Federation; Recruiting
Irina S Davidenko, Dr. 7 8612 33 79 39 irina_dav@mail.ru
7 861245 47 75
Irina S Davidenko, Dr., Principal Investigator


Regional State Medical Institution:”Orel Oncological Center”, Oncology Department #5, Orel, 302020, Russian Federation; Recruiting
Valery I Demchenko, Dr. 7 4862 41 00 11 ood@orel.ru
Alexander P Pechiony 7 4862 76 33 87
Alexander P Pechiony, Sub-Investigator
Valery I Demchenko, Dr., Principal Investigator


State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology, Ioshkar-Ola, 424037, Russian Federation; Recruiting
Vasily N Dubrovin, Dr. 7 8362 46 80 14 vndubrovin@mail.ru
7 902 67 16 992
Vasily N Dubrovin, Dr., Principal Investigator


State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department, Omsk, 644013, Russian Federation; Recruiting
Rinat K Galiulin, Dr. 7 3812 60 16 59 rinat-galiulin@bk.ru
Vladimir V Serov 7 3812 60 16 59 doctorhorror@mail.ru
Vladimir V Serov, Sub-Investigator
Andrey M Manankov, Sub-Investigator
Rinat K Galiulin, Dr., Principal Investigator


State Higher Educational Institution: St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development, Department of Allergology and Clinical Pharmacology, St. Petersburg, 194100, Russian Federation; Recruiting
Anna N Galustyan, Prof. 7 812 295 46 23 annagalustyan@nm.ru
Ivan Sardaryan 7 812 295 46 23 vanya77@rambler.ru
Anna N Galustyan, Prof., Principal Investigator
Ivan Sardaryan, Sub-Investigator


State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center, Chemotherapy Department, Chelyabinsk, 454087, Russian Federation; Recruiting
Oleg A Gladkov, Dr. 7 3512 32 93 76 gladkov_o@rambler.ru
Markova, Dr.
Markova, Dr., Sub-Investigator
Oleg A Gladkov, Dr., Principal Investigator


St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics, St.Petersburg, 194354, Russian Federation; Recruiting
Andrei I Gorelov, Prof. 7 812 296 30 01
Dmitry S Gorelov 7 812 972 48 87 sutura@mail.ru
Andrei I Gorelov, Prof., Principal Investigator
Dmitry S Gorelov, Sub-Investigator
Alexander S Mangushlo, Sub-Investigator
Vladimir A Fadeev, Sub-Investigator


Federal State Medical Institution «Central Medical Unit#122 under the Federal Department of Medicobiologic Agency», Department of Urology, St. Petersburg, 194291, Russian Federation; Recruiting
Sergei I Gorelov, Prof. 7 812 558 92 32 s_gorelov@mail.ru
Vasily G Grigoryev 7 905 279 06 69
Vasily G Grigoryev, Sub-Investigator
Victor P Gorelov, Sub-Investigator
Sergei I Gorelov, Prof., Principal Investigator


State Higher Educational Institution: Siberian State Medical University, Department of Urology, Tomsk, ,, 634050, Russian Federation; Recruiting
Alexander V Gudkov, Prof. 7 3822 41 98 51 cobra@mail.tomsknet.ru
Vyacheslav S Boshchenko 7 3822 41 75 78
Alexander V Gudkov, Prof., Principal Investigator
Vyacheslav S Boshchenko, Sub-Investigator


Spain
Hospital de Cruces, Vizcaya, 48903, Spain; Not yet recruiting
Guillermo L Vivanco +34 94 600 63 99


Ukraine
Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department, Dnepropetrovsk, 49044, Ukraine; Recruiting
Igor Bondarenko '+38 0562 58 53 72
Igor N. Bondarenko, Principal Investigator
IIya Balakin, Sub-Investigator
Viktor Zavizion, Sub-Investigator
Marina Zavizion, Sub-Investigator
Olga Skry'lnyk, Sub-Investigator
Vladimir Krasnov, Sub-Investigator
Yevheny Ukrayinets, Sub-Investigator


Lugansk Regional Clinical Oncological Center, Urology Department, Lugansk, 91047, Ukraine; Recruiting
Vladislav Rodovich +38 0642 54 25 84
Leonid P. Chibisov, Principal Investigator
Vladislav Rodovich, Sub-Investigator
Viktor Kharchenko, Sub-Investigator


Crimean Republican Clinical Oncological Center, Chemotherapy Department, Simferopol, 95023, Ukraine; Not yet recruiting
Galyna Koshukova +38 067 923 57 82 Koshukova@rambler.ru
Tatiana A Danilova, Principal Investigator
Galyna Koshukova, Sub-Investigator


Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy, Chernovtsy, 58000,, Ukraine; Not yet recruiting
Roman Senyutovich +38 097 472 19 78,
Anatoliya Gontsa, Principal Investigator
Roman Senyutovich, Sub-Investigator
Eduard Oliynik, Sub-Investigator
Yuriy Semehen, Sub-Investigator
Irena Gontsa, Sub-Investigator


Uzhgorod National University,, Uzhorod, 88000, Ukraine; Recruiting
Roman Selyanchyn +38 050 547 78 92,
Yevhen S. Hotko, Principal Investigator
Roman Selyanchyn, Sub-Investigator
Dmitriy Kovalchuk, Sub-Investigator
Valeriy Mondik, Sub-Investigator
Irina Hotko, Sub-Investigator
Dmitriy Prygara, Sub-Investigator


Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department, Kiev, 04053, Ukraine; Not yet recruiting
V. Sacalo +38 044 424 13 29
Ivan A. Klymenko, Principal Investigator
V. Sacalo, Sub-Investigator


Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department, Krivoy Rog, 50048, Ukraine; Recruiting
Anna Komisarenko +38 050 340 23 32,
Vladimir G. Komisarenko, Principal Investigator
Anna Komisarenko, Sub-Investigator
Grigoriy Adamchuk, Sub-Investigator
Alla Nikitenko, Sub-Investigator


Odessa State Medical University;, Odessa, 65074, Ukraine; Recruiting
Vladimir Shvets +38 0482 61 92 08
Fedor I. Kostev, Principal Investigator
Vladimir Shvets, Sub-Investigator
Sergey Filippov, Sub-Investigator
Valeriy Hodos, Sub-Investigator
Viktor Lysenko, Sub-Investigator


Ivano-Frankovsk State Medical University; Oncology Department, Ivanovo-Frankovsk, 76000, Ukraine; Recruiting
Tatiana Teren +38 0342 77 54 77
Ippolit Y. Kostinksy, Principal Investigator
Tatiana Teren, Sub-Investigator
Igor Zalala, Sub-Investigator
Nikolay Valchishin, Sub-Investigator


Zaporozhye Medical Academy of Postgraduate Education, Oncology Department, Zaporozhye, 69096, Ukraine; Recruiting
Feroz Shah +38 097 523 56 93
Alexey A. Kovalev, Principal Investigator
Feroz Shah, Sub-Investigator
Andrey Ryaboshapka, Sub-Investigator
Aleksey Lomeyko, Sub-Investigator
Konstantin Kovalev, Sub-Investigator


Zaporozhye Medical Academy of Postgraduate Education, Urology Department, Zaporozhye, 69600, Ukraine; Not yet recruiting
Alexey A. Lyulko '+38 0612 95 82 42
Alexey Lyulko, Principal Investigator


Dnepropetrovsk State Medical Academy, Department of Urology, Dnepropetrovsk, 49005, Ukraine; Recruiting
Robert Molchanov +38 050 530 83 98 rob_molch@yahoo.com
Alexey V. Lyulko, Principal Investigator
Robert Molchano, Sub-Investigator
Victor Stus', Sub-Investigator


Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department, Kharkov, 61176, Ukraine; Recruiting
Svetlana V. Antipenko +38 050 275 84 33 alex@khocod.kharkov.ua,
Tatiana N. Popovska, Principal Investigator
Svetlana V. Antipenko, Sub-Investigator
Natalia Otchenash, Sub-Investigator


Donetsk Regional Antitumor Center, Urology Department, Donetsk, 83092, Ukraine; Not yet recruiting
Sergey Paniyev +38 050 591 69 86
Igor E Sedakov, Principal Investigator
Sergey Paniyev, Sub-Investigator
Roman Osipenkov, Sub-Investigator


Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department, Lviv, 79010, Ukraine; Recruiting
Taras Kachmar +38 0322 23 09 72
Yaroslav V Shparyk, Principal Investigator
Taras Kachmar, Sub-Investigator
Olga Oleksyak, Sub-Investigator
Natalia Kitsera, Sub-Investigator


Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department, Kiev, 04053, Ukraine; Not yet recruiting
Oleg Voilenko '+38 044 489 39 76
Eduard A. Stakhovsky, Principal Investigator
Olrg Voilenko, Sub-Investigator
Vladimir Kotov, Sub-Investigator
Aleksandr Stakhovsky, Sub-Investigator


United Kingdom
Beatson Oncology Centre, Glasgow, G11 6NT, United Kingdom; Not yet recruiting
John Graham 0 141 211 6356
John Graham, Principal Investigator


Christie Hospital NHS Trust, Manchester, M20 4BX, United Kingdom; Recruiting
Robert Hawkins 0161 446 3269
Robert Hawkins, Principal Investigator


St. James University Hospital, Leeds, LS9 7TF, United Kingdom; Recruiting
Nicola Goldman 0113 2065668
Peter Selby, Principal Investigator


University of Nottingham, Nottingham, NG5 1PB, United Kingdom; Not yet recruiting
Karen Asher 0115 82 31850
Poulam Patel, Principal Investigator


Weston Park Hospital, Sheffield, S10 2SJ, United Kingdom; Not yet recruiting
Barry Hancock 0114 226 5007
Barry Hancock, Principal Investigator


St Luke's Cancer Centre, Royal Surrey County Hospital, Surrey, GU2 7XX, United Kingdom; Not yet recruiting
Hardev Pandha 01483 571122
Hardev Pandha, Principal Investigator


The Churchill Hospital, Oxford, OX3 7LJ, United Kingdom; Not yet recruiting
Andrew Protheroe 01865 266183
Andrew Protheroe, Principal Investigator


The South West Wales Cancer Institute, Swansea, SA2 8QA, United Kingdom; Not yet recruiting
John Wagstaff 01792 285 299


Southampton University Hospital, Southampton, SO16 6YD, United Kingdom; Not yet recruiting
Dr Geldart 023 8079 4202
Dr Geldart, Principal Investigator


St Mary's Hospital, Portsmouth, PO3 6AD, United Kingdom; Not yet recruiting
Dr Gale 023 8079 4202
Dr Gale, Principal Investigator


Bristol Haematology and Oncology Centre, Bristol, BS2 8ED, United Kingdom; Not yet recruiting
Amit K. Bahl
Amit K Bahl, Principal Investigator


Northern Centre for Cancer Treatment, Newcastle upon Tyne, NE4 6BE, United Kingdom; Not yet recruiting
Rhona M McMenemin 0191 256 3568
Rhona McMenemin, Principal Investigator


The James Cook University Hospital, Middlesbrough, TS4 3BW, United Kingdom; Not yet recruiting
Alison Humphrey 01642 854 091
Alison Humphrey, Principal Investigator


United Kingdom, N. Ireland
Belfast City Hospital, Belfast, N. Ireland, United Kingdom; Not yet recruiting
Alison Clayton 07740 477471
Alison Clayton, Principal Investigator


United Kingdom, Wirral
Clatterbridge Centre for Oncology, Bebington, Wirral, CH63 4JY., United Kingdom; Not yet recruiting
Ernie Marshall 0151 334 4000
Ernie Marshall, Principal Investigator

More Information

Study ID Numbers: TV3/001/06
Last Updated: March 23, 2007
Record first received: November 8, 2006
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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