Leptomeningeal Metastasis From Malignant Melanoma Clinical Trial
Official title:
Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
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.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Neurologische Universitaetsklinik Bonn | Bonn |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Bonn | Mundipharma Research GmbH & Co KG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety/Tolerance | The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events. | 30 weeks | Yes |
| Secondary | Delay of treatments | Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy). | 30 weeks | No |
| Secondary | Response rate | Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria. | 30 weeks | No |
| Secondary | Progression | Neurological progression, progression free survival, overall survival. | 30 weeks | No |