Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

This study is currently recruiting participants.
Verified June 2012 by University of Regensburg
Sponsor:
Information provided by (Responsible Party):
Peter Hau, University of Regensburg
ClinicalTrials.gov Identifier:
NCT01614132
First received: April 26, 2012
Last updated: March 20, 2014
Last verified: June 2012
  Purpose

The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.


Condition Intervention Phase
Medulloblastoma
Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)
Radiation: Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • feasibility of the adjuvant chemotherapy [ Time Frame: participants will be followed for the duration of chemo therapy, an expected average of 1 year ] [ Designated as safety issue: Yes ]

    The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far.

    The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .



Secondary Outcome Measures:
  • Number of performable cycles in chemo therapy [ Time Frame: participants will be followed for the duration of chemo therapy, an expected average of 6 months ] [ Designated as safety issue: Yes ]
    It should be determined how many cycles in the maintenance chemotherapy are feasible.

  • 3 and 5 years progression-free survival [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ] [ Designated as safety issue: Yes ]
    The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.

  • event-free survival [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ] [ Designated as safety issue: Yes ]
    The event-free survival (efs) should be determined for adult patients.

  • overall survival [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ] [ Designated as safety issue: Yes ]
    The overall survival (os) should be determined for adult patients.

  • course of cognitive performance/QoL [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ] [ Designated as safety issue: No ]
    The course of the cognitive performance and the quality of life should be observed.


Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vincristin, CCNU, cis-platin

radio chemotherapy (7 cycles of 7 days):

  • 2 mg/m2 vincristin i.v.
  • 55,0 Gy Posterior cranial fossa (M0)
  • 55,0 Gy Posterior cranial fossa / cerebral metastases + 49,6 Gy spinal metastases (M1-M3)

maintenance chemotherapy (8 cycles of 42 days):

  • once at day 1 at each cycle: 70 mg/m2 cis-platin i.v. 75 mg/m2 CCNU oral 2 mg/m2 vincristin i.v.
  • once at day 8 and 15 at each cycle: 2 mg/m2 vincristin i.v.
Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)
maintenance chemotherapy of maximum of 8 cycles á 42 days
Other Names:
  • Vincristin: L01CA02
  • CCNU: Lomustin L01AD02
  • cis-platin: L01XA01
Radiation: Radiotherapy
Radiotherapy of the partial brain

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively
  • primary diagnosis of the tumor
  • no previous chemo- or radiation therapy
  • Karnofsky-Index ≥ 70%
  • WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl
  • creatinine =< 1,5 ULN; Bilirubin =< 1,5 ULN; GPT, GOT, AP =< 2,5 ULN
  • HIV and hepatitis B/C negative
  • no factors / any medical condition affecting patient's compliance
  • patient needs to fulfil protocol's requirements
  • patient is willing to use highly effective methods of contraception during dosing and for 6 months after the last dose; women of child-bearing potential must have a negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4 weeks
  • patient's written consent

Exclusion Criteria:

  • age < 18 years
  • histologically not confirmed Medulloblastoma
  • by chemo- or radiotherapy treated recidive tumor
  • other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)
  • hypersensitivity or contraindication against one of the used drugs
  • current or planned participation to another clinical trial during this study Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study
  • Any medical condition associated with high medical risk or contraindicated to use chemotherapeutic agents as indicated in current product package insert
  • Pregnant or nursing (lactating) women; women or men not willing to use a highly effective methods of contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614132

Contacts
Contact: Ulrich Bogdahn, Prof. +49-941-941 ext 3001 ulrich.bogdahn@medbo.de
Contact: Peter Hau, Prof. +49-941-941 ext 8083 peter.hau@medbo.de

Locations
Germany
Universitätsklinikum RWTH Withdrawn
Aachen, Germany, 52074
Vivantes Netzwerk für Gesundheit GmbH Recruiting
Berlin, Germany, 10249
Contact: Dag Moskopp, Prof.    030-130-23 ext 1760    dag.moskopp@vivantes.de   
Neurologische Universitätsklinik Recruiting
Bochum, Germany, 44892
Contact: Uwe Schlegel, Prof. Dr.    0234/299-3701    neurologie@kk-bochum.de   
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53105
Contact: Ulrich Herrlinger, Prof.    +49-228-287 ext 6848    ulrich.herrlinger@ukb.uni-bonn.de   
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Astrid Weyerbrock, Prof.    +49-761-270 ext 5100    astrid.weyerbrock@uniklinik-freiburg.de   
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Tobias Martens, Dr.    +49-40-7410 ext 57054    t.martens@uke.uni-hamburg.de   
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Michael Bremer, PD Dr.    +49-511-532-3590    bremer.michael@mh-hannover.de   
Universitätsklinikum Heidelberg Active, not recruiting
Heidelberg, Germany, 69120
Klinikum der Universität zu Köln Recruiting
Köln, Germany, 50937
Contact: Jürgen Hampl, Prof. Dr.    +49-221-478-4577    juergen.hampl@uk-koeln.de   
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Rolf-Dieter Kortmann, Prof.    +493 41 97 - 1 84 00    Rolf-Dieter.Kortmann@uniklinik-leipzig.de   
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany, 23538
Contact: Matteo Mario Bonsanto, Dr.    + 49 451 5006183    matteo.bonsanto@uk-sh.de   
Otto-von-Guericke Universität Recruiting
Magdeburg, Germany, 39120
Contact: Thomas Schneider, PD Dr.    +49 391 6721350    thomas.schneider@medizin.uni-magdeburg.de   
Johannes Gutenberg-Universität Mainz Active, not recruiting
Mainz, Germany, 55131
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Walter Stummer, Prof. Dr.       Walter.Stummer@ukmuenster.de   
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Peter Hau, Prof.    +49-941-941 ext 8464    neuroonkologie@medbo.de   
Katharinenhospital Recruiting
Stuttgart, Germany, 70174
Contact: Helmut Welker, Dr.    +49-711-278 ext 4233    h.welker@katharinenhospital.de   
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Daniel Zips, Prof. Dr.    +49-7071-29 ext 82165    ROInfo@med.uni-tuebingen.de   
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Regine Mayer-Steinacker, Prof.    +49 731-500-56056    regine.mayer-steinacker@uniklinik-ulm.de   
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Ulrich Bogdahn, MD Department of Neurology, University of Regensburg
  More Information

No publications provided

Responsible Party: Peter Hau, Head, Clinical Neurooncology, University of Regensburg
ClinicalTrials.gov Identifier: NCT01614132     History of Changes
Other Study ID Numbers: NOA-07
Study First Received: April 26, 2012
Last Updated: March 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:
medulloblastoma
CNS
malignant neoplasm
NOA
neuroectodermal tumor
Vincristin
CCNU
Cisplatin

Additional relevant MeSH terms:
Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cisplatin
Lomustine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014