Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 0 to 30 Other EUDRACT 2005-002618-40 BfArM-4030755, EC-105/05, DKS 2006.01, NCT00749723

Trial Description

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.

Further Study Information

Parts of the study:

P-HIT-REZ-2005: a randomised trial for the treatment of relapsed PNETs (medulloblastomas,supratentorial PNETs)

E-HIT-REZ-2005: a nonrandomized 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitaetsklinikum Bonn

Gudrun Fleischhack, MD

Principal Investigator

Gudrun Fleischhack, MD		Ph: +49 228 287 33254
		Email: gudrun.fleischhack@ukb.uni-bonn.de

Udo Bode, MD		Ph: +49 228 287 33210
		Email: udo.bode@ukb.uni-bonn.de

Germany
	Aachen
	Kinderklinik - Universitaetsklinikum Aachen
	Augsburg
	Klinikum Augsburg
	Berlin
	Charite University Hospital - Campus Virchow Klinikum
	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
	Bielefeld
	Evangelisches Krankenhauus Bielfeld
	Bonn
	Kinderklinik der Universitaet Bonn
	Braunschweig
	Staedtisches Klinikum Braunschweig
	Bremen
	Klinikum Bremen-Mitte
	Cottbus
	Carl - Thiem - Klinkum Cottbus
	Datteln
	Vestische Kinderklinik
	Dortmund
	Klinikum Dortmund
	Dresden
	Universitatsklinikum Carl Gustav Carus
	Duisburg
	Klinikum Duisburg
	Düsseldorf
	Universitaetsklinikum Duesseldorf
	Erfurt
	Helios Klinikum Erfurt
	Erlangen
	Universitaets - Kinderklinik
	Essen
	Universitaetsklinikum Essen
	Frankfurt/Main
	Klinikum der J.W. Goethe Universitaet
	Freiburg
	Universitaetskinderklinik - Universitaetsklinikum Freiburg
	Gießen
	Kinderklinik
	Göttingen
	Universitaetsklinikum Goettingen
	Greifswald
	Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
	Halle/Saale
	University Children's Hospital
	Hannover
	Medizinische Hochschule Hannover
	Heidelberg
	Universitaets-Kinderklinik Heidelberg
	Herdecke
	Gemeinschaftskrankenhaus
	Homburg/Saar
	Universitaetsklinikum des Saarlandes
	Jena
	Universitaets - Kinderklinik
	Karlsruhe
	Staedtisches Klinikum Karlsruhe gGmbH
	Kassel
	Klinikum Kassel
	Kiel
	University Hospital Schleswig-Holstein - Kiel Campus
	Koblenz
	Klinikum Kemperhof Koblenz
	Köln
	Children's Hospital
	Leipzig
	Universitaets - Kinderklinik
	Lübeck
	Universitaets - Kinderklinik - Luebeck
	Ludwigshafen
	St. Annastift Krankenhaus
	Magdeburg
	Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
	Mainz
	Universitatsklinik Mainz
	Mannheim
	Staedtisches Klinik - Kinderklinik
	Marburg
	Universitaets - Kinderklinik
	Minden
	Klinikum Minden
	München
	Dr. von Haunersches Kinderspital der Universitaet Muenchen
	Kinderklinik d. TU / Schwabing
	Münster
	Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
	Nürnberg
	Cnopf'sche Kinderklinik
	Oldenburg
	Klinikum Oldenburg
	Regensburg
	Klinik St. Hedwig-Kinderklinik
	Rostock
	Kinderklinik - Universitaetsklinikum Rostock
	Stuttgart
	Olgahospital
	Tübingen
	Universitaets-Kinderklinik
	Ulm
	Universitaetsklinik fuer Kinder - und Jugendmedizin - Universitaetsklinikum Ulm
	Würzburg
	Universitaets - Kinderklinik Wuerzburg

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00749723
Information obtained from ClinicalTrials.gov on September 09, 2008