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No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.
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| Name | Class |
|---|---|
| Mundipharma Research GmbH & Co KG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS) | Radiation | Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerance | The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events. | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Delay of treatments | Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy). | 30 weeks |
| Response rate | Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Glas, PD Dr. | Neurologische Universitaetsklinik Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologische Universitaetsklinik Bonn | Bonn | 53127 | Germany |
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| Lomustine | Drug | Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. |
|
| Liposomal cytarabine | Drug | Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. |
|
| 30 weeks |
| Progression | Neurological progression, progression free survival, overall survival. | 30 weeks |
| ID | Term |
|---|---|
| D008130 | Lomustine |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
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