Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

NCT ID: NCT01614132

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2018-10-31

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.

Conditions

Medulloblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

maintenance chemotherapy (vincristin, cisplatin and CCNU)

Intervention Type: DRUG

maintenance chemotherapy of maximum of 8 cycles á 42 days

Radiotherapy

Intervention Type: RADIATION

Radiotherapy of the partial brain

Interventions

maintenance chemotherapy (vincristin, cisplatin and CCNU)

maintenance chemotherapy of maximum of 8 cycles á 42 days

Intervention Type: DRUG

Radiotherapy

Radiotherapy of the partial brain

Intervention Type: RADIATION

Other Intervention Names

Vincristin: L01CA02; CCNU: Lomustin L01AD02; cis-platin: L01XA01

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Peter Hau

Head, Clinical Neurooncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Hau, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Regensburg

Locations

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

Neurologische Universitätsklinik

Bochum, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Medizinische Hochschule Hannover

Hanover, , 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, , Germany

Countries

Germany

Other Identifiers

NOA-07

Identifier Type: -

Identifier Source: org_study_id