Spots Global Cancer Trial Database for Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
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Trial Identification
Brief Title: Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
Official Title: Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.
Study ID: NCT00761280
Study Description
Brief Summary: In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV).
Detailed Description: The purpose of this study is to compare the safety and efficacy of the 10 µM concentration of AP 12009 and standard chemotherapy (temozolomide, BCNU, CCNU) in adult patients with recurrent or refractory anaplastic astrocytoma (AA, WHO grade III) or secondary glioblastoma (GBM, WHO grade IV). AP 12009 (trabedersen) is a phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human Transforming Growth Factor beta 2 (TGF-beta-2), which is applied intratumorally. The growth factor TGF-beta plays a key role in malignant progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis, and escape from immunosurveillance. In patients with high-grade glioma, the TGF-beta-2 overexpression is associated with disease stage, clinical prognosis, and the immunodeficient state of the patients. Main objective of the study is to determine survival (rate) and tumor response. Important note: Due to early trial termination, resulting in limited data availability, all analyses remain descriptive by nature, only. No conclusive endpoint analysis can be performed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
NJ Neuroscience Institute; JFK Medical Center, Edison, New Jersey, United States
Winthrop University Hospital, Mineola, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Hospital Británico, Ciudad Autónoma de Buenos Aires, , Argentina
FLENI, Ciudad Autónoma de Buenos Aires, , Argentina
Sanatorio Allende, Córdoba, , Argentina
Universitätsklinik Innsbruck, Abteilung für Neurologie, Innsbruck, , Austria
AKH Wien, Klinik für Neurochirurgie, Wien, , Austria
Hospital de Câncer de Barretos, Barretos / SP, , Brazil
Centro Goiano de Oncologia (CGO), Goiania, , Brazil
Hospital Sao Vicente de Paulo, Passo Fundo, , Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, , Brazil
Hospital do Servidor Público Estadual, Sao Paulo, , Brazil
ECOGENE-21 Centre d'études cliniques, Chicoutimi, Quebec, Canada
Foothills Medical Centre, Calgary, , Canada
Montreal Neurological Institute and Hospital, Montreal, , Canada
La Timone University Hospital, Marseille, , France
Klinik und Poliklinik für Neurochirurgie, Frankfurt/M., , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Neurochirurgische Klinik an der Universität Ulm am Bezirkskrankenhaus Günzburg, Günzburg, , Germany
Universitätklinikum Hamburg-Eppendorf, Klinik für Neurochirurgie, Hamburg, , Germany
Medizinische Hochschule Hannover Neurochirurgische Klinik, Hannover, , Germany
Universitätsklinik Heidelberg Neurologische Klinik, Heidelberg, , Germany
Universitätsklinikum Leipzig, Neurochirurgische Klinik, Leipzig, , Germany
Otto-von-Guericke-Universität, Klinik für Neurochirurgie, Magdeburg, , Germany
Klinik und Poliklinik für Neurochirurgie, Münster, , Germany
Klinik und Poliklinik für Neurologie, Regensburg, , Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Manipal Hospital & Manipal Institute for Neurological Disorders, Bangalore, , India
NIMHANS, Bangalore, , India
BGS Global Hospital, Bangalore, , India
Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, , India
Apollo Speciality Hospitals, Chennai, , India
Amrita Institute of Medical Sciences Research Center, Cochin, , India
Care Hospitals, Hyderabaad, , India
AMRI Hospitals, Kolkata, , India
SGPGI of Medical Sciences, Lucknow, , India
Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Mumbai, , India
All India Institute of Medical Sciences (AIIMS), New Delhi, , India
SCTIMST, Dept. of Neurosurgery, Thiruvananthapuram, , India
Severance Hospital, Yonsei University College of Medicine, Seoul, , Korea, Republic of
Kangnam St. Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hospital San Javier, Guadalajara, , Mexico
Hospital General de Mexico, Mexico City, , Mexico
Medica Sur, Mexico City, , Mexico
Wojskowy Szpital Kliniczny, Klinika Neurochirurgii, Bydgoszcz, , Poland
Akademickie Centrum Kliniczne, Gdańsk, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Neurochirurgii i Neurochirurgii Dziecięcej, Lublin, , Poland
Kliniczny Oddzial Neurochirurgii SUM w Sosnowcu Wojewódzki Szpital Specjalistyczny nr 5, Sosnowiec, , Poland
Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie, Warszawa, , Poland
SP ZOZ Uniwersytecki Szpital Kliniczny nr 1, Klinika Neurochirurgii, Łódź, , Poland
Chelyabinsk City Hospital #3; Department of Neurosurgery, Chelyabinsk, , Russian Federation
State Institution Russian Oncology Research Center N.N. Blokhin, Moscow, , Russian Federation
Samara Region Clinical Hospital M.I. Kalinin, Samara, , Russian Federation
Russian Scientific Research Neurosurgical Institute A.L. Polenov, St. Petersburg, , Russian Federation
Military Medical Academy, Neurosurgery Dept, St. Petersburg, , Russian Federation
Hospital de Cruces, Baracaldo, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Doce de Octubre, Madrid, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Tri-Service General Hospital, Taipei City, , Taiwan
Edinburgh Centre for Neuro-Oncology, Western General Hospital, Edinburgh, , United Kingdom
The National Hospital for Neurology and Neurosurgery, London, , United Kingdom
Contact Details
Name: Rolando Del Maestro, MD, PhD
Affiliation: Montreal Neurological Institute and Hospital
Role: STUDY_CHAIR
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