Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
- Conditions
- Medulloblastoma
- Interventions
- Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)Radiation: Radiotherapy
- Registration Number
- NCT01614132
- Lead Sponsor
- University of Regensburg
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vincristin, CCNU, cis-platin maintenance chemotherapy (vincristin, cisplatin and CCNU) 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. Vincristin, CCNU, cis-platin Radiotherapy 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.
- Primary Outcome Measures
Name Time Method feasibility of the adjuvant chemotherapy 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
Name Time Method Number of performable cycles in chemo therapy 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 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 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 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 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.
Trial Locations
- Locations (15)
Neurologische Universitätsklinik
🇩🇪Bochum, Germany
Vivantes Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Otto-von-Guericke Universität
🇩🇪Magdeburg, Germany
Katharinenhospital
🇩🇪Stuttgart, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany