Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

Medulloblastoma Clinical Trial

— NOA-07  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614132
• Other study ID #: NOA-07
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2009
• Est. completion date: October 2018

Study information

• Verified date: March 2020
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Medulloblastoma

Intervention

Drug:
• maintenance chemotherapy (vincristin, cisplatin and CCNU)
maintenance chemotherapy of maximum of 8 cycles á 42 days

Radiation:
• Radiotherapy
Radiotherapy of the partial brain

Locations

Country	Name	City	State
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	Neurologische Universitätsklinik	Bochum
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Otto-von-Guericke Universität	Magdeburg
Germany	Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Münster	Münster
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Katharinenhospital	Stuttgart
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	participants will be followed for the duration of chemo therapy, an expected average of 1 year
Secondary	Number of performable cycles in chemo therapy	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
Secondary	3 and 5 years progression-free survival	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
Secondary	event-free survival	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
Secondary	overall survival	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
Secondary	course of cognitive performance/QoL	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