Medulloblastoma
Conditions
Keywords
medulloblastoma, CNS, malignant neoplasm, NOA, neuroectodermal tumor, Vincristin, CCNU, Cisplatin
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.
Interventions
DRUGmaintenance chemotherapy (vincristin, cisplatin and CCNU)
maintenance chemotherapy of maximum of 8 cycles á 42 days
RADIATIONRadiotherapy
Radiotherapy of the partial brain
Sponsors
University of Regensburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed