Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter Hau, University of Regensburg
ClinicalTrials.gov Identifier:
NCT01614132
First received: April 26, 2012
Last updated: May 14, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614132

Locations
Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, Germany, 10249
Neurologische Universitätsklinik
Bochum, Germany, 44892
Universitätsklinikum Bonn
Bonn, Germany, 53105
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinikum der Universität zu Köln
Köln, Germany, 50937
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Otto-von-Guericke Universität
Magdeburg, Germany, 39120
Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Universitätsklinikum Münster
Münster, Germany, 48149
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Katharinenhospital
Stuttgart, Germany, 70174
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Universitätsklinikum Ulm
Ulm, Germany, 89081
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: May 14, 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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014