Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 18 and over Pharmaceutical / Industry 06762004 NCT00420888

Trial Description

Summary

The drug ABR-217620 is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620 when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed RCC (clear cell and papillary types)

• Metastatic or inoperable locally advanced RCC

• Eligible for therapy with IFN-alpha.

• Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)

• Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)

• Karnofsky performance status greater than or equal to 70

• Age greater than or equal to 18

• Life expectancy greater than 3 months

• Baseline blood counts:

• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L

• Platelets greater than or equal to 100 x 10^9/L

• Haemoglobin greater than or equal to 100 g/L

• Baseline blood chemistry levels:

• Creatinine less than or equal to 1.5 x upper limit of normal (ULN)

• Bilirubin less than or equal to 2 x ULN

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. AST and ALT allowed less than or equal to 5 x ULN for patients with liver metastases.

• If fertile, patient will use effective method of contraception throughout the study

• Willing and able to comply with the treatment and follow-up visits and examinations

• Capable of understanding the parameters in the protocol and able to sign a written consent form

Exclusion Criteria:

• Pregnant or breastfeeding women

• Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug

• History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included

• History and/or signs of parenchymal brain metastases

• Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.

• History of stroke within 5 years and/or transient ischemic attack within 6 months.

• Acute illness or evidence of infection, including unexplained fever (>100.5ºF or 38.1ºC) within 2 weeks before start of treatment

• Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit

• Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620 treatment

• Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study

• Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis

• Known positive serology for HIV

• Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed

• Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line

• Radiotherapy less than 4 weeks before start of treatment

• Major surgery or tumor embolization less than 4 weeks before start of treatment

• Previous exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins

• Currently on renal dialysis treatment

• Known allergy or hypersensitivity to aminoglycosides and kanamycin

• Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-alpha or IL-2 or any chemotherapy) except sunitinib or other oral antiangiogenic therapy

• Participation in any study with investigational drugs for RCC within 6 weeks

Trial Contact Information

Trial Lead Organizations/Sponsors

Active Biotech

Thore Nederman, PhD

Study Director

Republic of Bulgaria
	Pleven
	Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
		Nina Ivanova, MD	Ph: 359 64 886 312
			Email: nina2ivanova@yahoo.com
		Nina Ivanova, MD	Principal Investigator
	Plovdiv
	1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
		Olga Mateva	Ph: 359 32 772 265
			Email: olga_mateva@yahoo.com
		Antoaneta Tomova, MD	Principal Investigator
	Sofia
	University Hospital Queen Joanna
		Valentina Tzekova, Assoc. Prof.	Ph: 359 2 9432 472
			Email: tzekova@technolink.com
		Valentina Tzekova, Assoc. Prof.	Principal Investigator
	Varna
	Urology Clinic, General Hospital for Active Treatment "St. Anna"
		Vesselin Stamboliiski, MD	Ph: 359 52 213 64 22
		Lidia Petkova, Assoc. Prof.	Principal Investigator
	Veliko Tarnovo
	Regional Oncology Dispensary with Inpatient Sector
		Gyulyay Kokoeva	Ph: 359 62 620 249
			Email: onkovt@vachev.com
		Mariya Racheva, MD	Principal Investigator
Romania
	Bucharest
	Clinical Hospital "Prof. Dr. Th. Burghele"
		Viorel Jinga, MD	Ph: 40 21 410 69 10
			Email: viorel_jinga@hotmail.com
		Viorel Jinga, MD	Principal Investigator
	Dinu Uromedica
		Marius Dinu, MD	Ph: 40 21 332 03 56
			Email: dinu.marius@xnet.ro
		Marius Dinu, MD	Principal Investigator
	Institutul Clinic Fundeni
		Mihai Harza, MD	Ph: 40 21 311 46 45
		Mihai Harza, MD	Principal Investigator
	Cluj Napoca
	E-URO Medical Center
		Ioan Coman, Assoc. Prof.	Ph: 40 264 406 718
			Email: icoman@yahoo.com
		Ioan Coman, Assoc. Prof.	Principal Investigator
	Institutul Oncologic - Universitatea de Medicina
		Tudor Ciuleanu, MD	Ph: 40 264 598 361
			Email: tudor_ec2002@yahoo.fr
		Tudor Ciuleanu, MD	Principal Investigator
	Constanta
	Provita 2000 SRL
		Laurentiu Babu, MD	Ph: 40 241 517 274
			Email: laur_babu@yahoo.com
		Laurentiu Babu, MD	Principal Investigator
	Sibiu
	Clinical County Hospital of Sibiu
		Nicolae Grigore, Assoc. Prof.	Ph: 40 269 215 050
			Email: nicolaegrigore2000@yahoo.com
		Nicolae Grigore, Assoc. Prof.	Principal Investigator
	Timisoara
	Oncomed SRL
		Anca Niculescu, MD	Ph: 40 256 495 403
		Anca Niculescu, MD	Principal Investigator
Russia
	Arkhangelsk
	Arkhangelsk Oblast Clinical Oncological Hospital
		A. Arkhipov, MD	Ph: 78182 275 269
			Email: aokod@rambler.ru
		A. Arkhipov, MD	Principal Investigator
	Chelyabinsk
	Chelyabinsk Regional Oncology Center
		Oleg A. Gladkov, MD	Ph: 7 3512 32 93 76
			Email: gladkov_o@rambler.ru
		Oleg A. Gladkov, MD	Principal Investigator
	Kazan
	Republican Clinical Oncology Center
		Guzel Z. Mukhametshina, MD	Ph: 7 843 519 26 00
		Rustem S. Khasanov, Prof.	Principal Investigator
	Tatarstan Republican Clinical Oncology Center
		Sufia Z. Safina, MD	Ph: 7 843 292 07 41
			Email: ksafin@mail.ru
		Sufia Z. Safina, MD	Principal Investigator
	Moscow
	Research Institute of Urology
		Andrey V. Sivkov, MD	Ph: 7 495 164 76 60
			Email: sivkov@uro.ru
		Nickolay A. Lopatkin, Prof.	Principal Investigator
	Russian Academy of Medical Sciences Cancer Research Center
		Vsevolod B. Matveev, Prof.	Ph: 7 495 324 44 89
		Vsevolod B. Matveev, Prof.	Principal Investigator
	Russian Research Center for Roentgen Radiology
		Andrei D. Kaprin, Prof.	Ph: 7 495 333 90 60
		Andrei D. Kaprin, Prof.	Principal Investigator
	Obninsk
	Medical Radiological Research Center of Russian Academy of Medical Sciences
		Kadir N. Safiullin, MD	Ph: 7 48439 9 30 44
			Email: safiulin@mrrc.obninsk.ru
		Oleg B. Karyakin, Prof.	Principal Investigator
	Orenburg
	Orenburg Regional Clinical Oncology Center
		Dmitry V. Kirsanov, MD	Ph: 7 3532 33 21 92
			Email: mammologichcentr@rambler.ru
		Dmitry V. Kirsanov, MD	Principal Investigator
	St. Petersburg
	Central Research Institute of Roentgenology and Radiology
		Denis G. Prokhorov, MD	Ph: 7 812 596 87 68
			Email: prokhor_off@mail.ru
		Mikhail I. Shkolnik, MD	Principal Investigator
	Leningrad Regional Oncological Center
		Ivan L. Pulin, MD	Ph: 7 812 273 74 42
			Email: ivan_pulin@mail.ru
		Laslo D. Roman, MD	Principal Investigator
	Municipal Aleksandrovskaya Hospital
		Andrey A. Prischepov, MD	Ph: 7 812 583 16 11
		Andrey A. Prischepov, MD	Principal Investigator
	Municipal Clinical Oncology Center
		Piotr A. Karlov, MD	Ph: 7 812 376 89 20
		Piotr A. Karlov, MD	Principal Investigator
	Municipal Hospital #15
		Konstantin A. Dunets, MD	Ph: 7 812 736 90 47
		Vakhtang A. Shanava, MD	Principal Investigator
	Municipal Hospital #26
		Mikhail I. Forkampf-Laue, MD	Ph: 7 812 723 32 03
			Email: mforkampf@yandex.ru
		Sergei L. Mikhailov, MD	Principal Investigator
	Municipal Multi-Speciality Hospital #2
		Alexander A. Mangushlo, MD	Ph: 7 812 296 30 01
		Andrey I. Gorelov, Prof.	Principal Investigator
	Petrov Research Institute of Oncology
		Alexander K. Nosov, MD	Ph: 7 812 596 86 02
		Georgy I. Gafton, MD	Principal Investigator
	Stavropol
	Stavropol Regional Oncology Center
		Islam M. Laipanov, MD	Ph: 7 8652 38 30 41
		Sergei M. Mikhailov, MD	Principal Investigator
	Yaroslavl
	Regional Oncology Center - Yaroslavl
		Olga V. Dylinova, MD	Ph: 7 4852 72 10 44
			Email: homeleon@nordnet.ru
		Sergei V. Cheporov, MD	Principal Investigator
Ukraine
	Cherkassy
	Cherkassy Regional Oncology Center
		Viacheslav A. Askolsky, MD	Ph: 380 472 47 00 21
			Email: onkods@ch.ukrtel.net
		Viacheslav A. Askolsky, MD	Principal Investigator
	Chernigov
	Chernigov Regional Oncology Center
		Vladimir N. Zotov, MD	Ph: 380 4622 599 55
			Email: dokpolenkov@rambler.ru
		Vladimir N. Zotov, MD	Principal Investigator
	Dnepropetrovsk
	City General Hospital #4
		Igor N. Bondarenko, Prof.	Ph: 380 562 58 53 72
			Email: oncology@dsma.dp.ua
		Igor N. Bondarenko, Prof.	Principal Investigator
	Urology Department, Dnepropetrovsk State Medical Academy
		Alexey V. Lyulko, Prof.	Ph: 380 562 46 41 83
			Email: urolog@svitonline.com
		Alexey V. Lyulko, Prof.	Principal Investigator
	Donetsk
	Donetsk Regional Antitumor Center
		Vladimir G. Bondar, MD	Ph: 380 622 23 98 00
			Email: ostapy@rambler.ru
		Vladimir G. Bondar, MD	Principal Investigator
		Yury V. Dumansky, Prof.	Ph: 380 622 23 87 10
			Email: anischenko@interdon.ne
		Yury V. Dumansky, Prof.	Principal Investigator
	Ivano-Frankovsk
	Ivano-Frankovsk Regional Oncology Center
		Ippolit Y. Kostinsky, Prof.	Ph: 380 342 77 54 77
			Email: teren70@inbox.ru
		Ippolit Y. Kostinsky, Prof.	Principal Investigator
	Kharkiv
	Kharkiv Regional Urology and Nephrology Center
		Vladimir N. Lesovoy, Prof.	Ph: 380 577 38 71 55
			Email: khareba@rambler.ru
		Vladimir N. Lesovoy, Prof.	Principal Investigator
	Kiev
	Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department
		Valery S. Sakalo, MD	Ph: 380 44 424 13 29
			Email: garryrrr@i.com.ua
		Valery S. Sakalo, MD	Principal Investigator
	Lvov
	State Regional Diagnostics and Treatment Oncology Center
		Yaroslav V. Shparyk, Prof.	Ph: 380 322 23 07 67
			Email: shp@org.lviv.net
		Yaroslav V. Shparyk, Prof.	Principal Investigator
	Uzhorod
	Uzhgorod Regional Oncology Dispensary
		Evgeny S. Gotko, MD	Ph: 380 312 61 51 40
			Email: eugene@tn.uz.ua
		Evgeny S. Gotko, MD	Principal Investigator
United Kingdom
	Cambridge
	Addenbrooke's Hospital
		Tim Eisen, Prof.	Ph: 44 1223 404 191
			Email: tgg2@cam.ac.uk
		Tim Eisen, Prof.	Principal Investigator
	Derby
	Derby Hospital NHS Trust
		Prabir Chakraborti, MD	Ph: 44 1332347141
			Email: prabir.chakraborti@derbyhospitals.nhs.uk
		Prabir Chakraborti, MD	Principal Investigator
	Glasgow
	Beatson West of Scotland Cancer Centre
		Robert J. Jones, MD	Ph: 44 1413017176
			Email: r.jones@beatson.gla.ac.uk
		Robert J. Jones, MD	Principal Investigator
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Janet Brown, MD	Ph: 44 1132067817
			Email: janet.brown@leedsth.nhs.uk
		Janet Brown, MD	Principal Investigator
	London
	Royal Marsden - London
		Martin Gore, Prof.	Ph: 44 20 7808 2198
			Email: martin.gore@rmh.nhs.uk
		Martin Gore, Prof.	Principal Investigator
	Manchester
	Christie Hospital
		Robert E. Hawkins, Prof.	Ph: 0161 446 3473
			Email: rhawkins@PICR.man.ac.uk
		Robert E. Hawkins, Prof.	Principal Investigator
	Swansea
	South Wales Cancer Institute, Singleton Hospital
		John Wagstaff, Prof.	Ph: 44 1792285547
			Email: john.wagstaff@swansea-tr.wales.nhs.uk
		John Wagstaff, Prof.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00420888
Information obtained from ClinicalTrials.gov on September 26, 2008