Overview

This trial is active, not recruiting.

Condition medulloblastoma
Treatments maintenance chemotherapy (vincristin, cisplatin and ccnu), radiotherapy
Phase phase 1/phase 2
Sponsor University of Regensburg
Start date January 2009
End date September 2020
Trial size 30 participants
Trial identifier NCT01614132, NOA-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
maintenance chemotherapy (vincristin, cisplatin and ccnu) Vincristin: L01CA02
maintenance chemotherapy of maximum of 8 cycles á 42 days
radiotherapy
Radiotherapy of the partial brain

Primary Outcomes

Measure
feasibility of the adjuvant chemotherapy
time frame: 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
time frame: participants will be followed for the duration of chemo therapy, an expected average of 6 months
3 and 5 years progression-free survival
time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
event-free survival
time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
overall survival
time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
course of cognitive performance/QoL
time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
Principal investigator Peter Hau, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Regensburg.