Clinical trial NCT01614132: Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
Official title: Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Medulloblastoma
Keywords: medulloblastoma
CNS
malignant neoplasm
NOA
neuroectodermal tumor
Vincristin
CCNU
Cisplatin
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: feasibility of the adjuvant chemotherapy
timeFrame: participants will be followed for the duration of chemo therapy, an expected average of 1 year
Secondary outcomes:
measure: Number of performable cycles in chemo therapy
timeFrame: participants will be followed for the duration of chemo therapy, an expected average of 6 months
measure: 3 and 5 years progression-free survival
timeFrame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
measure: event-free survival
timeFrame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
measure: overall survival
timeFrame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
measure: course of cognitive performance/QoL
timeFrame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Bochum
country: Germany
facility: Neurologische Universitätsklinik
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Magdeburg
country: Germany
facility: Otto-von-Guericke Universität
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität Mainz
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Katharinenhospital
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Department of Neurology, University of Regensburg
name: Peter Hau, MD
role: PRINCIPAL_INVESTIGATOR
References: