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| Sponsor: | immatics Biotechnologies GmbH |
|---|---|
| Information provided by: | immatics Biotechnologies GmbH |
| ClinicalTrials.gov Identifier: | NCT00785122 |
Purpose
This study is being conducted in order to determine whether IMA910 as single agent with GM-CSF as adjuvant following pre-treatment with low-dose cyclophosphamide is safe and shows sufficient anti-tumour effectiveness in patients with advanced CRC to warrant further development. The regular study duration for individual patients comprises regularly 3-6 weeks of screening, 33 weeks of treatment (16 vaccinations) and 4 weeks follow-up. Thus, the period between start of screening and end of study is about 10 months per patient. Patients will be withdrawn from study treatment once a progress according to RECIST is noted. An enrolment plan for the first 6 patients included in this study will be used to ensure maximum safety of the study participants.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Carcinoma |
Drug: Endoxana, IMA910, Leukine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open Label, Multicenter Phase 1-2 Study to Investigate the Effectiveness, Safety and Immunogenicity of a Monotherapy With Intradermal IMA910 Plus GM-CSF Following Pre-treatment With Low-dose Cyclophosphamide in Advanced Colorectal Carcinoma Patients Who Have Successfully Completed a 12 Week First-line Treatment With Oxaliplatin-based Chemotherapy. |
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following abnormal laboratory values:
Haematology:
Hb <9 g/dL WBC <2.5 x 109/L Neutrophils <1.5 x 109/L Lymphocytes <1.0 x 109/L Platelets <75 x 109/L
Liver function:
Serum bilirubin >1.5 x upper normal limit (unless a history of Gilbert's disease) ALAT or ASAT >3 x upper normal limit (>5 x ULN if liver metastases are present) Alkaline Phosphatase >3 x upper normal limit (>5 x ULN if liver metastases are present)
Patients with other significant diseases currently uncontrolled by treatment which might interfere with study completion, including gastrointestinal, hepatic, renal, respiratory, cardiovascular, haematological, coagulation, metabolic or hormonal diseases with clinically relevant abnormal organ function for example:
Contacts and Locations| Contact: Andrea Mayer-Mokler | +49 7071 565 125 ext 18 | mayer@immatics.com |
| Contact: Jürgen Frisch, MD | +49 7071 565 125 ext 13 | frisch@immatics.com |
| Belgium | |
| Oncologisch Centrum, UZ Gent | Recruiting |
| Gent, Belgium, 9000 | |
| Contact: Tine Derre +32/93325125 tine.derre@ugent.be | |
| Principal Investigator: Marc Peeters, Prof. Dr. | |
| Medische Oncologie, Imeldaziekenhuis | Not yet recruiting |
| Bonheiden, Belgium, 2820 | |
| Contact: Doreen Iwens +32/15504712 Doreen.Iwens@imelda.be | |
| Principal Investigator: Veerle Moons, MD | |
| Germany | |
| Internistische onkologische Studienzentrale | Active, not recruiting |
| Dresden, Germany, 01307 | |
| Krankenhaus Nordwest der Stiftung Hospital zum heiligen Geist, II. med. Klinik | Active, not recruiting |
| Frankfurt a.M., Germany, 60488 | |
| University of Tübingen, Department of med. Oncology, Hematology, Immunology, Rhematology and Pulmology | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Corinna Jäth +49/7071-29-80611 corinna.jaeth@med.uni-tuebingen.de | |
| Principal Investigator: Frank Mayer, PD Dr. Dr. | |
| Universitätsklinikum Ulm, Dep. Of Internal Medicine I, Studiensekretariat, CCCU, CTOA | Recruiting |
| Ulm, Germany, 89081 | |
| Contact: Yvonne Kriebisch +49/731-500-44764 ivonne.kriebisch@uniklinik-ulm.de | |
| Principal Investigator: Götz von Wichert, PD Dr. | |
| Kliniken Villingen, Schwarzwald-Baar-Klinik, Dept. Of Hematology & Oncology | Recruiting |
| Villingen-Schwenningen, Germany, 78050 | |
| Contact: Yasmin Hoffmann +49/7721-93-4022 yasmin.hoffmann@sbk.vs.de | |
| Principal Investigator: Wolfram Brugger, Prof. Dr. | |
| Prosper-Hospital, Med. Klinik I | Recruiting |
| Recklinghausen, Germany, 45659 | |
| Contact: Annette Schröder +49/23-61-54-15029 annette.schroeder@prosper-hospital.de | |
| Principal Investigator: Thomas Höhler, Prof. Dr. | |
| Medical School Hannover, MHH, Gastroenterologie | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: Monique Hörning +49/511-532-6779 hoerning.monique@mh-hannover.de | |
| Principal Investigator: Stefan Kubicka, Prof. Dr. | |
| Hungary | |
| National Institute of Oncology, Department of Internal Medicine, Department of Chemotherapy "B" | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Erika Hitre, MD +36/30-430-15-13 hitre@oncol.hu | |
| Contact: Atila Kiss | |
| Principal Investigator: Istvan Lang, MD | |
| Állami Egészségügyi Központ (volt MÀV Kórház), Dept. of Oncology | Not yet recruiting |
| Budapest, Hungary, 1062 | |
| Contact: Geza Lakner, MD | |
| Principal Investigator: Geza Lakner, MD | |
| Uszoki Hospital | Not yet recruiting |
| Budapest, Hungary, 1145 | |
| Contact: Màrta Baki, MD | |
| Principal Investigator: Màrta Baki, MD | |
| Semmelweis University, Oncoradiology | Recruiting |
| Budapest, Hungary, 1085 | |
| Contact: Edit Pthö +36/208-258-824 dank@radi.sote.hu | |
| Principal Investigator: Magdolna Dank | |
| Péterfy Hospital | Recruiting |
| Budapest, Hungary, 1076 | |
| Contact: Tamas Magyar, MD | |
| Principal Investigator: Tamas Magyar, MD | |
| University of Szeged, Department of Oncotherapy | Recruiting |
| Szeged, Hungary, 6720 | |
| Contact: Zita Ferenczi +36/62-544-984 ferenczi@onko.szote.u-szeged.hu | |
| Principal Investigator: László Thurzo, MD | |
| Latvia | |
| Pauls Stradins University Hospital | Recruiting |
| Riga, Latvia, 1002 | |
| Contact: Aiga Gaile | |
| Principal Investigator: Gunta Purkalne, Prof. Dr. | |
| Latvia oncological Center | Recruiting |
| Riga, Latvia, 1079 | |
| Contact: Marina Vudmaska | |
| Principal Investigator: Zanete Zvirbule, Prof. Dr. | |
| Poland | |
| SPZOZ Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Onkologii | Not yet recruiting |
| Krakow, Poland, 31-501 | |
| Contact: Joanna Huszno | |
| Principal Investigator: Janusz Pawlega, Prof. Dr. | |
| Klinika Chemioterapii Nowotworów, Regionalny Ośrodek Onkologiczny, Wojewódzki Szpital Specjalistyczny im. M.Kopernika Uniwersytetu Medycznego Łódz | Not yet recruiting |
| Lodz, Poland, 93-509 | |
| Contact: Anna Pluszanska, Prof. Dr. | |
| Principal Investigator: Anna Pluszanska, Prof. Dr. | |
| Katedra i Klinika Hematologii, Onkologii i Cherob Wewnetrznych AM SP Centralny Szpital Kliniczny w Warszawie | Recruiting |
| Warszawa, Poland, 02-097 | |
| Contact: Anna Swieboda, MD | |
| Principal Investigator: Wieslaw Wiktor Jedrzejzczak, Prof. Dr. | |
| Serbia | |
| Institute for Oncology and Radiology of Serbia, National Cancer Research Center, Clinical Research and Exp. Pharmacology | Recruiting |
| Belgrade, Serbia, 11000 | |
| Contact: Zorika Marinkovic | |
| Principal Investigator: Sinisa Radulovic, Prof. Dr. | |
| Oncology Institute of Vojvodina | Recruiting |
| Sremska, Serbia, 21204 | |
| Contact: Ivan Nikolic, MD +381/214-805-569 nikolic.ivan@onko.onk.ns.ac.yu | |
| Principal Investigator: Dusan Jovanovic, Prof. Dr. | |
| Study Director: | Andrea Mayer-Mokler | immatics biotechnolgies GmbH |
More Information
| Responsible Party: | immatics biotechnologies GmbH ( Andrea Mayer-Mokler ) |
| Study ID Numbers: | EudraCT Nr. 2007-005666-12 |
| Study First Received: | November 4, 2008 |
| Last Updated: | December 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00785122 History of Changes |
| Health Authority: | Germany: Paul-Ehrlich-Institut; Belgium: Federal Agency for Medicines and Health Products; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: State Institute for Drug Control; Serbia: Agency for Medicines and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Cyclophosphamide Rectal Diseases Oxaliplatin Neoplasms by Site Therapeutic Uses Alkylating Agents Digestive System Neoplasms Neoplasms by Histologic Type |
Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Myeloablative Agonists Gastrointestinal Neoplasms Antineoplastic Agents, Alkylating Antirheumatic Agents Colorectal Neoplasms Neoplasms, Glandular and Epithelial |