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

Primary Purpose

Medulloblastoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
maintenance chemotherapy (vincristin, cisplatin and CCNU)
Radiotherapy
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medulloblastoma focused on measuring medulloblastoma, CNS, malignant neoplasm, NOA, neuroectodermal tumor, Vincristin, CCNU, Cisplatin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vivantes Netzwerk für Gesundheit GmbH
  • Neurologische Universitätsklinik
  • Universitätsklinikum Bonn
  • Universitätsklinikum Freiburg
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Schleswig-Holstein
  • Otto-von-Guericke Universität
  • Johannes Gutenberg-Universität Mainz
  • Universitätsklinikum Münster
  • Universitätsklinikum Regensburg
  • Katharinenhospital
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Ulm

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vincristin, CCNU, cis-platin

Arm Description

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.

Outcomes

Primary Outcome Measures

feasibility of the adjuvant chemotherapy
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
It should be determined how many cycles in the maintenance chemotherapy are feasible.
3 and 5 years progression-free survival
The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.
event-free survival
The event-free survival (efs) should be determined for adult patients.
overall survival
The overall survival (os) should be determined for adult patients.
course of cognitive performance/QoL
The course of the cognitive performance and the quality of life should be observed.

Full Information

First Posted
April 26, 2012
Last Updated
March 27, 2020
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT01614132
Brief Title
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
Acronym
NOA-07
Official Title
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma
Keywords
medulloblastoma, CNS, malignant neoplasm, NOA, neuroectodermal tumor, Vincristin, CCNU, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vincristin, CCNU, cis-platin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
maintenance chemotherapy (vincristin, cisplatin and CCNU)
Other Intervention Name(s)
Vincristin: L01CA02, CCNU: Lomustin L01AD02, cis-platin: L01XA01
Intervention Description
maintenance chemotherapy of maximum of 8 cycles á 42 days
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy of the partial brain
Primary Outcome Measure Information:
Title
feasibility of the adjuvant chemotherapy
Description
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 .
Time Frame
participants will be followed for the duration of chemo therapy, an expected average of 1 year
Secondary Outcome Measure Information:
Title
Number of performable cycles in chemo therapy
Description
It should be determined how many cycles in the maintenance chemotherapy are feasible.
Time Frame
participants will be followed for the duration of chemo therapy, an expected average of 6 months
Title
3 and 5 years progression-free survival
Description
The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.
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
Title
event-free survival
Description
The event-free survival (efs) should be determined for adult patients.
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
Title
overall survival
Description
The overall survival (os) should be determined for adult patients.
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
Title
course of cognitive performance/QoL
Description
The course of the cognitive performance and the quality of life should be observed.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hau, MD
Organizational Affiliation
Department of Neurology, University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Neurologische Universitätsklinik
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Otto-von-Guericke Universität
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

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