Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Peter Hau, University of Regensburg
First received: April 26, 2012
Last updated: October 31, 2016
Last verified: October 2016
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.
Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
The course of the cognitive performance and the quality of life should be observed.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2020 (Final data collection date for primary outcome measure)
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
- Vincristin: L01CA02
- CCNU: Lomustin L01AD02
- cis-platin: L01XA01
Radiotherapy of the partial brain
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.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01614132
|Vivantes Netzwerk für Gesundheit GmbH
|Berlin, Germany, 10249 |
|Bochum, Germany, 44892 |
|Bonn, Germany, 53105 |
|Freiburg, Germany, 79106 |
|Medizinische Hochschule Hannover
|Hannover, Germany, 30625 |
|Heidelberg, Germany, 69120 |
|Leipzig, Germany, 04103 |
|Lübeck, Germany, 23538 |
|Magdeburg, Germany, 39120 |
|Johannes Gutenberg-Universität Mainz
|Mainz, Germany, 55131 |
|Münster, Germany, 48149 |
|Regensburg, Germany, 93053 |
|Stuttgart, Germany, 70174 |
|Tübingen, Germany, 72076 |
|Ulm, Germany, 89081 |
University of Regensburg
||Peter Hau, MD
||Department of Neurology, University of Regensburg
||Peter Hau, Head, Clinical Neurooncology, University of Regensburg
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 26, 2012
||October 31, 2016
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Keywords provided by Peter Hau, University of Regensburg:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 27, 2017
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic