Thursday, April 22, 2010
Trovax (like BCG MBV coley's toxins)
Renal cell carcinoma
http://en.wikipedia.org/wiki/TroVax#Renal_cell_carcinoma
http://en.wikipedia.org/wiki/Coley%27s_Toxins
http://bioinfo.tg.fh-giessen.de/pamp-cancer/introduction/
"Mixed Bacterial Vaccine" (MBV)
Trovax is administered in combinations with interleukin-2, interferon-alpha, sunitinib to combat advanced or metastatic renal cell carcinoma to 700 patients, with the primary endpoint being the rate of overall survival. There is a Special Protocol Assessment agreement with the FDA that specifies the design, conduct, analysis and endpoints of the trial.
Trovax works by targeting the 5T4 antigen--a protein that is found on 85% of solid tumors. The idea is that by targeting this protein Trovax instigates an immune response enabling the body to fight the cancer.
See the Oxford BioMedica website for more information.
TroVax uses a tumor-associated antigen, 5T4, with a pox virus vector. 5T4 is found in a wide range of solid cancers and its presence is correlated with poor prognosis.
http://en.wikipedia.org/wiki/TroVax#Renal_cell_carcinoma
Das Produkt besteht aus einem Pockenvirus-(MVA)-Gentransfersystem, welches das Gen für 5T4 bereitstellt und den Körper von Patienten zu einer Anti-5T4-Immunantwort anregt.
ClinicalTrials.gov Home Search Study Topics Glossary
TroVax Renal Immunotherapy Survival Trial
This study is ongoing, but not recruiting participants.
First Received: November 8, 2006 Last Updated: March 10, 2008 History of Changes
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
Biological: Trovax
Phase III
Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.
Resource links provided by NLM:
MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: 5T4 cancer vaccine
U.S. FDA Resources
Further study details as provided by Oxford BioMedica:
Primary Outcome Measures:
* overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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.
2: Placebo Comparator Biological: Trovax
1ml IM injection 2-8 weeks apart.
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-? (excluding pegylated IFN?)
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.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397345
Hide Study Locations
Locations
United States, Arizona
AZ Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Little Rock Hematology / Oncology Associates, P.A.
Little Rock, Arkansas, United States, 72205
United States, California
The Angeles Clinic and Reseach Institute
LA, California, United States, 90025
La Jolla, CA
La Jolla, California, United States, 92093
1300 N. Vermont Ave
Los Angeles, California, United States, 90027
UCLA Urology/Oncology
Los Angeles, California, United States, 90095
Scripps Cancer Center
San Diego, California, United States, 92121
Sharp Health Care
San Diego, California, United States, 92823
United States, Colorado
UCHSC
Aurora, Colorado, United States, 80045
United States, District of Columbia
Washington Cancer Center
Washington, District of Columbia, United States, 20010
United States, Florida
Broward Oncology Associates
Ft Lauderdale, Florida, United States, 33308
SCORE Physician Alliance
Saint Petersburg, Florida, United States, 33709
SCORE Physician Alliance
Saint Petersburg, Florida, United States, 33710
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Augusta Oncology Associates
Augusta, Georgia, United States, 30901
SMO-USA Inc.
Canton, Georgia, United States, 301115
United States, Idaho
North Idaho Cancer Centre
Coeur D'Alene, Idaho, United States, 83814
United States, Illinois
Patricia A. Joyce Cancer Institute
Olympia Fields, Illinois, United States, 60461
Edward H Kaplan and Associates
Skokie, Illinois, United States, 60076
United States, Indiana
St Francis Hospital
Indianapolis, Indiana, United States, 46107
Cancer Care Centre of Indiana
New Albany, Indiana, United States, 47150
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
Henry Ford Health System / Josephine Ford Cancer Center
Detroit, Michigan, United States, 48202
United States, Minnesota
University Minnesota Fairview Medical Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Haematology and Oncology Associates at Bridgeport
Tupelo, Mississippi, United States, 38801
United States, Montana
Charleston Hematology and Oncology Associates,
Billings, Montana, United States, 59101
Billings Clinical Research Center
Billings, Montana, United States, 59107
United States, Nevada
Freedman Urology
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
The Cancer Center @ HUMC
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Pluta Cancer Centre
Rochester, New York, United States, 14623
United States, Ohio
Piedmont Hospital, Inc.
Canton, Ohio, United States, 30309
Riverside Cancer Centre
Columbus, Ohio, United States, 43214
Heamatology and Oncology Associates Inc.
Columbus, Ohio, United States, 43235
Flower Hospital/ Promedica Health System
Sylvania, Ohio, United States, 43560
United States, Oregon
Oregon Urology Institute
Springfield, Oregon, United States, 97477
United States, South Carolina
Cancer Centre of the Carolinas
Greenville, South Carolina, United States, 29605
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
The Methodist Hospital
Houston, Texas, United States, 77030
Urology Associates of South Texas
McAllen, Texas, United States, 78503
United States, Virginia
Cancer Outreach Associates PC
Abingdon, Virginia, United States, 24211
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Madigan Army Medical Centre
Tacoma,, Washington, United States, 98109
France
CHU Besançon Hôpital Minjoz
Besancon, France, 25030
Centre François Baclesse-CLCC-Caen
Caen, France, 14076
Centre Francois Baclesse
Caen, France, 14076
Germany
Universitätsklinikum C.G. Carus TU Dresden
Dresden, Germany, 01307
Israel, Zerifin
Oncology department, Assaf Harofeh Medical Center
P.O.Beer Yaacov, Zerifin, Israel, 70300
Israel
Oncology institute , Rambam /health Care Campus
Haifa, Israel, 31096
Meir Medical Center
Kfar Saba, Israel, 44281
Oncology department Rabin Medical center
Petach Tikva, Israel, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Oncology institute , The Chaim Sheba Medical center
Tel- Hashomer, Israel, 52621
Poland
IIndependent Public Clinical Hospital #1- Academic Clinical Center of Medical Academy in Gdan'sk, Oncology and Radiotherapy Department
Gdan'sk, Poland, 80-952
Holycross Oncology Center in Kielce, Department of Urology
Kielce, Poland, 25-734
Maria Sklodowska-Curie Memorial Institute, Oncology Center in Kraków, Clinic of Systemic and Generalized Neoplasms
Krakow, Poland, 31-115
Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology
Kraków, Poland, 31-501
Lord's Transfiguration Independent Public Clinical Hospital # 1 of Medical Academy in Poznan', Department of Chemotherapy
Poznan, Poland, 61-848
Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic
Szczecin, Poland, 70-111
Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System
Warsaw, Poland, 02-781
Military Institute of Medicine, Department of Oncology
Warsaw,, Poland, 00-909
Regional Specialistic Hospital in Wroc?aw, Department of Urology
Wroc?aw, Poland, 51-124
Romania
Private Medical Centre
Arad,, Romania, 310175
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
Bucharest, Romania
Dinu Uromedica
Bucharest,, Romania, 041345
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
Bucharest,, Romania, 050659,
Fundeni Clinical Institute - Urology Department
Bucharest,, Romania, 022328
"I. Chiricuta" Institute of Oncology
Cluj-Napoca, Romania, 400015,
E-URO Medical Center
Cluj-Napoca,, Romania, 400420
Provita Center SRL
Constant,a, Romania, 900635
Sibiu Clinical County Hospital - Urology Clinic
Sibiu,, Romania, 550245
Oncomed SRL
Timisoara,, Romania, 300239
Russian Federation, Leningrad Region
Leningrad Regional Oncological Center, Surgical Department #3
St Petersburg, Leningrad Region, Russian Federation, 188663
Russian Federation, Pyatigorsk
Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department
Stavropol Krai, Pyatigorsk, Russian Federation, 357500
Russian Federation, Republic of Karelia
Republican Oncology Center" under the Ministry of Healthcare, Social Development and Sports of the Republic of Karelia, Outpatient Department
Petrozavodsk, Republic of Karelia, Russian Federation, 185007
Russian Federation, Republic of Tatarstan
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, 420029
Russian Federation
State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.
Arkhangelsk, Russian Federation, 163045
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center, Chemotherapy Department
Chelyabinsk, Russian Federation, 454087
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,
Chelyabinsk, Russian Federation, 454087
State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology
Ioshkar-Ola, Russian Federation, 424037
Municipal Medical Institution: Oncological Center, Chemotherapy Department
Krasnodar, Russian Federation, 350040
Federal State Institution: Russian Research Center of Roentgenology & Radiology under the Federal Agency for Healthcare and Social Development, Surgery Department
Moscow, Russian Federation, 117997
Non-State Medical Institution:Central Clinical Hospital #2 n.a. N.A. Semashko under OAO Russian Railways, Chemotherapy Department
Moscow, Russian Federation, 129128
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology
Moscow, Russian Federation, 117997
State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology
Moscow, Russian Federation, 115478
Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen
Moscow, Russian Federation, 125284
Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1
Moscow, Russian Federation, 129110
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy
Moscow, Russian Federation, 117997
Murmansk Regional Oncological Center, Oncology Department #5
Mumansk, Russian Federation, 183047
Federal State Institution: Privolzhsky County Medical Center under the Federal Agency for Healthcare and Social Development, Urology Department #2
Nizhny Novgorod, Russian Federation, 603001
State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)
Nizhny Novgorod, Russian Federation, 603081
Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology
Obninsk, Russian Federation, 249036
State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department
Omsk, Russian Federation, 644013
Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5
Orel, Russian Federation, 302020
Orenburg Regional Clinical Oncological Center, Chemotherapy Department
Orenburg, Russian Federation, 460021
Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology
Rostov-on-Don, Russian Federation, 344022
Regional Clinical Oncological Center, Surgery Department
Ryazan, Russian Federation, 390011
Samara Regional Oncology Center, Chemotherapy Department
Samara, Russian Federation, 443066
"Oncological Center", Department of Haematology and Chemotherapy
Sochi, Russian Federation, 354057
Research Institute of Oncology n.a. Professor N.N. Petrov under the Federal Agency for Healthcare and Social Development, Department of Biotherapy and Bone Marrow Transplantation
St Petersburg, Russian Federation, 197758
"Central Research Institute of Roentgenology & Radiology under the Federal Agency for Healthcare and Social Development", Department of Surgery and Endovascular Radiology in Urologic Oncology
St Petersburg, Russian Federation, 197758
Municipal Multi-Speciality Hospital #2, Department of Urology
St Petersburg, Russian Federation, 194354
Municipal Hospital #26, Department Of Urology
St Petersburg, Russian Federation, 196247
Federal State Medical Institution "Central Medical Unit#122 under the Federal Department of Medicobiologic Agency", Department of Urology
St. Petersburg, Russian Federation, 194291
St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department
St. Petersburg, Russian Federation, 198205
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, Russian Federation, 194100
St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics
St.Petersburg, Russian Federation, 194354
State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology
Stavropol, Russian Federation, 355047
State Medical Institution: Tambov Regional Oncological Center, Surgery Department
Tambov, Russian Federation, 392013
State Higher Educational Institution: Siberian State Medical University, Department of Urology
Tomsk, ,, Russian Federation, 634050
Bashkir State Medical University, Urology Department
Ufa, Russian Federation, 634050
State Medical Institution of Yaroslavl Region "Regional Clinical Oncological Hospital", Chemotherapy Department
Yaroslavl, Russian Federation, 150054
Spain, Madrid
Hospital Severo Ochoa, Servicio de Oncologia - Primera planta
Leganes, Madrid, Spain, S
Spain
Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica
Barcelona, Spain, 080025
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Marques de Valdecilla Consultas de Oncologia 1st planta
Santander, Spain, 39008
Hospital de Cruces
Vizcaya, Spain, 48903
Ukraine
Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy
Chernovtsy, Ukraine, 58000,
Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department
Dnepropetrovsk, Ukraine, 49044
Dnepropetrovsk State Medical Academy, Department of Urology
Dnepropetrovsk, Ukraine, 49005
Donetsk Regional Antitumor Center, Urology Department
Donetsk, Ukraine, 83092
Ivano-Frankovsk State Medical University; Oncology Department
Ivanovo-Frankovsk, Ukraine, 76000
Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department
Kharkov, Ukraine, 61037
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department
Kharkov, Ukraine, 61176
Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department
Kiev, Ukraine, 04053
Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department
Kiev, Ukraine, 04053
Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department
Krivoy Rog, Ukraine, 50048
Lugansk Regional Clinical Oncological Center, Urology Department
Lugansk, Ukraine, 91047
Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department
Lviv, Ukraine, 79010
Odessa State Medical University;
Odessa, Ukraine, 65074
Crimean Republican Clinical Oncological Center, Chemotherapy Department
Simferopol, Ukraine, 95023
Uzhgorod National University,
Uzhorod, Ukraine, 88000
Zaporozhye Medical Academy of Postgraduate Education, Oncology Department
Zaporozhye, Ukraine, 69096
Zaporozhye Medical Academy of Postgraduate Education, Urology Department
Zaporozhye, Ukraine, 69600
United Kingdom, Middlesex
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
United Kingdom, N. Ireland
Belfast City Hospital
Belfast, N. Ireland, United Kingdom
United Kingdom, Wirral
Clatterbridge Centre for Oncology
Bebington, Wirral, United Kingdom, CH63 4JY.
United Kingdom
The Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Beatson Oncology Centre
Glasgow, United Kingdom, G11 6NT
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
University of Nottingham
Nottingham, United Kingdom, NG5 1PB
The Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
St Luke's Cancer Centre, Royal Surrey County Hospital
Surrey, United Kingdom, GU2 7XX
The South West Wales Cancer Institute
Swansea, United Kingdom, SA2 8QA
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Oxford BioMedica
More Information
No publications provided
Responsible Party: Oxford BioMedica ( Dr Mike McDonald )
Study ID Numbers: TV3/001/06
Study First Received: November 8, 2006
Last Updated: March 10, 2008
ClinicalTrials.gov Identifier: NCT00397345 History of Changes
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
Keywords provided by Oxford BioMedica:
Renal
TroVax
survival
metastatic
Kidney
cancer
immunotherapy
Locally advanced or metastatic, measurable, histologically proven clear cell renal carcinoma.
Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma
ClinicalTrials.gov processed this record on April 21, 2010
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