⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: