The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Neurologische Universitaetsklinik Bonn
Bonn, Germany
Safety/Tolerance
The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
Time frame: 30 weeks
Delay of treatments
Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
Time frame: 30 weeks
Response rate
Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
Time frame: 30 weeks
Progression
Neurological progression, progression free survival, overall survival.
Time frame: 30 weeks
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