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Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children

Information source: University Hospital, Bonn
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Brain Tumors; Supratentorial PNETs; Medulloblastomas; Ependymomas

Intervention: carboplatin (Drug); etoposide (Drug); temozolomide (Drug); thiotepa, carboplatin, etoposide (Drug); temozolomide, thiotepa (Drug); autologous stem cell transplantation (Procedure); etoposide (Drug); trofosfamide/etoposide (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital, Bonn

Official(s) and/or principal investigator(s):
Gudrun Fleischhack, MD, Principal Investigator, Affiliation: Department of Pediatric Hematology & Oncology, Pediatrics III, University Children's Hospital Essen

Summary

The purpose of this study is to improve overall survival while maintaining a good quality of life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas, supratentorial PNETs, ependymomas WHO grade II and III). Response to different chemotherapy options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a multimodal therapy will be assessed. Progression-free, overall survival and toxicity will be evaluated additionally.

Clinical Details

Official title: Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

P-HIT-REZ 2005 study: two Chemotherapy-arms: progression-free survival from therapy start and response evaluation after the fourth therapy course

E-HIT-REZ 2005 study (Phase II Study "Oral chemotherapy with temozolomide"): Evaluation of response rate to the 60-days oral chemotherapy with temozolomide

Phase II study "Intraventricular therapy with etoposide": Evaluation of response rate to the 5-week intraventricular therapy with etoposide

Secondary outcome:

P-HIT-REZ 2005 study: two Chemotherapy-arms: overall survival from start of therapy

E-HIT-REZ 2005 study: Chemotherapy-arm: progression-free survival from start of therapy

E-HIT-REZ 2005 study: Chemotherapy-arm: overall survival from start of therapy

E-HIT-REZ 2005 study: Chemotherapy-arm: toxicity rate (CTC)

Phase II study "Intraventricular therapy with etoposide": toxicity rate (CTC)

P-HIT-REZ 2005 study: two Chemotherapy-arms: toxicity rate (CTC) in both arms

Detailed description: Parts of the study: P-HIT-REZ-2005: a trial for the treatment of relapsed PNETs (medulloblastomas,supratentorial PNETs) E-HIT-REZ-2005: a trial for the treatment of relapsed ependymomas (Phase II-Study with temozolomide) Phase II-Study: intraventricular therapy with etoposide in neoplastic meningitis in relapsed PNETs and ependymomas with subarachnoid tumor manifestation (window study)

Eligibility

Minimum age: 3 Months. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Disease Characteristics

- Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma

- Refractory or relapsed disease

- Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid

Patients characteristics

- Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40%

- Life expectancy ≥ 8 weeks

Hematological:

- Absolute leukocyte count ≥ 2. 0 x 10^9 /l

- Hemoglobin ≥ 10g/dl

- Platelet count ≥ 70 x 10^9/l

Renal:

- Creatinine no greater than 1. 5 times UNL

- No overt renal disease

Hepatic:

- Bilirubin less than 2. 5 times UNL

- AST and ALT less than 5 times UNL

- No overt hepatic disease

Pulmonary:

- No overt pulmonary disease

Cardiovascular:

- No overt cardiovascular disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection Prior concurrent therapy

- More than 2 weeks since prior systemic chemotherapy

- More than 4 weeks since prior radiotherapy

- No other concurrent anticancer or experimental drugs Examinations required

- Examination of lumbar CSF

- Cranial and spinal MRI within 14 days prior to start of treatment

Locations and Contacts

Universitätskinderklinik Aachen, Aachen 52074, Germany

Klinikum Augsburg, Klinik für Kinder- und Jugendmedizin, Augsburg 86156, Germany

Charité Klinikum Campus Virchow, Kinderklinik, Berlin 13353, Germany

Helios Klinikum Berlin-Buch, Klinik für Kinderheilkunde und Jugendmedizin, Berlin 13125, Germany

Klinik ür Kinder- und Jugendmedizin in Bethel, Bielefeld 33617, Germany

Universitätskinderklinik Bonn, Bonn 53113, Germany

Städtisches Klinikum Braunschweig, Kinderklinik, Braunschweig 38118, Germany

Klinikum Bremen-Mitte, Bremen 28177, Germany

Carl-Thiele-Klinikum Cottbus, Zentrum für Kinderheilkunde, Cottbus 03048, Germany

Vestische Kinder- und Jugendklinik Datteln, Datteln 45711, Germany

Klinikum Dortmund, Klinik für Kinder- und Jugendmedizin, Dortmund 44137, Germany

Universitätsklinikum Dresden, Kinderklinik, Dresden 01307, Germany

Klinikum Duisburg, Klinik für Kinder-und Jugendmedizin, Duisburg 47055, Germany

Universitätskinderklinik Düsseldorf, Düsseldorf 40225, Germany

Helios Klinikum Erfurt, Zentrum für Kinderheilkunde, Erfurt 99089, Germany

Universitätskinderklinik Erlangen, Erlangen 91054, Germany

Universitätskinderklinik Essen, Essen 45122, Germany

Klinikum der Wolfgang Goethe Universität, Klinik für Kinderheilkunde, Frankfurt/Main 60590, Germany

Universitätskinderklinik Freiburg, Freiburg 79106, Germany

Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde, Gießen 35385, Germany

Universitätskinderklinik Greifswald, Greifswald 17475, Germany

Universitätskinderklinik Göttingen, Göttingen 37075, Germany

Martin-Luther-Universität Halle Wittenberg, Halle/Saale 06120, Germany

Universitätskinderklinik Hamburg-Eppendorf, Hamburg 20246, Germany

Medizinische Hochschule, Zentrum für Kinderheilkunde, Hannover 30625, Germany

Universitätskinderklinik Heidelberg, Heidelberg 69120, Germany

SLK Kinderklinik Heilbronn, Heilbronn 74078, Germany

Gemeinschaftskrankenhaus Herdecke, Kinderklinik, Herdecke 58313, Germany

Universitätskinderklinik, Homburg/Saar 66421, Germany

Friedrich Schiller Universität, Klinik für Kinder-und Jugendmedizin, Jena 07745, Germany

Städtisches Krankenhaus, Klinik für Kinder- und Jugendmedizin, Karlsruhe 76133, Germany

Klinikum Kassel, Kinderklinik, Kassel 34125, Germany

UKSH, Campus Kiel, Klinik für Allg. Pädiatrie, Kiel 24105, Germany

Städtisches Klinikum Kemperhof, Klinik für Kinder- und Jugendmedizin, Koblenz 56073, Germany

Universitätskinderklinik Köln, Köln 50924, Germany

Universitätskinderklinik Leipzig, Leipzig 04317, Germany

Universitätskinderklinik Lübeck, Lübeck 23538, Germany

Otto-von-Guericke-Universität, Zentrum für Kinderheilkunde, Magdeburg 39120, Germany

Universitätskinderklinik Mainz, Mainz 55131, Germany

Universitätskinderklinik Mannheim, Mannheim 68167, Germany

Universitätskinderklinik Marburg, Marburg 35043, Germany

Klinikum Minden III, Klinik für Kinder-und Jugendheilkunde, Minden 32432, Germany

Dr. von Haunersches Kinderspital, München 80337, Germany

Städtisches Krankenhaus München-Schwabing, Kinderklinik der TU München, München 80804, Germany

Universitätskinderklinik Münster, Münster 48129, Germany

Cnopf'sche Kinderklinik, Nürnberg 90419, Germany

Klinikum Oldenburg, Zentrum für Kinder-und Jugendmedizin, Oldenburg 26131, Germany

Universitäts-Kinderklinik, Regensburg 93042, Germany

Universitätskinderklinik Rostock, Rostock 18057, Germany

Asklepios Klinik St. Augustin GmbH, St. Augustin 53757, Germany

Olgahospital-Pädiatrisches Zentrum, Stuttgart 70176, Germany

Universitätskinderklinik Tübingen, Tübingen 72076, Germany

Univeritätsklinikum Ulm, Abteilung Kinder-und Jugendmedizin, Ulm 89075, Germany

Universitätskinderklinik Würzburg, Würzburg 97080, Germany

Additional Information

German Society of Pediatric Hematology and Oncology

German Children's Cancer Foundation

Starting date: February 2006
Last updated: July 7, 2015

Page last updated: August 23, 2015

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