A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma

Conditions
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Leptomeningeal Metastasis From Malignant Melanoma

Intervention / Treatment
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* Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
* Drug: Lomustine
* Drug: Liposomal cytarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. | Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)<br>* Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.<br>Drug: Lomustine<br>* Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.<br>Drug: Liposomal cytarabine<br>* Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 30 weeks | 
| Progression | Neurological progression, progression free survival, overall survival. | 30 weeks |