Leptomeningeal Metastasis From Malignant Melanoma
Conditions
Brief summary
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.
Interventions
RADIATIONBrain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
DRUGLomustine
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Sponsors
Mundipharma Research GmbH & Co KG
University Hospital, Bonn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour * CSF flow abnormalities must be excluded * Males or females ≥ 18 years of age * Karnofsky Performance Status \> 50% * Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)
Exclusion criteria
* Unresected parenchymal brain metastases with a diameter \> 3 cm * Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer) * Prior intrathecal chemotherapy * Prior treatment with systemic cytarabine or nitrosureas * The patient ist pregnant or breast feeding * Severe, active co-morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety/Tolerance | 30 weeks | The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delay of treatments | 30 weeks | Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy). |
| Response rate | 30 weeks | Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria. |
| Progression | 30 weeks | Neurological progression, progression free survival, overall survival. |
Countries
Germany
Outcome results
None listed