Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)

March 27, 2020 updated by: Peter Hau, University of Regensburg

Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10249
        • Vivantes Netzwerk für Gesundheit GmbH
      • Bochum, Germany, 44892
        • Neurologische Universitatsklinik
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke Universität
      • Mainz, Germany, 55131
        • Johannes Gutenberg-Universität Mainz
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Stuttgart, Germany, 70174
        • Katharinenhospital
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vincristin, CCNU, cis-platin

radiotherapy and concomitant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of the adjuvant chemotherapy
Time Frame: participants will be followed for the duration of chemo therapy, an expected average of 1 year

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 .
participants will be followed for the duration of chemo therapy, an expected average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
It should be determined how many cycles in the maintenance chemotherapy are feasible.
participants will be followed for the duration of chemo therapy, an expected average of 6 months
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
The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.
participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
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
The event-free survival (efs) should be determined for adult patients.
participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
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
The overall survival (os) should be determined for adult patients.
participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
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
The course of the cognitive performance and the quality of life should be observed.
participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Peter Hau, MD, Department of Neurology, University of Regensburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOA-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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