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
Phase 1
Terminated
- Conditions
- Leptomeningeal Metastasis From Malignant Melanoma
- Interventions
- Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
- Registration Number
- NCT01563614
- Lead Sponsor
- University Hospital, Bonn
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS) Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. Treatment Liposomal cytarabine Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. Treatment Lomustine Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
- Primary Outcome Measures
Name Time Method Safety/Tolerance 30 weeks The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
- Secondary Outcome Measures
Name Time Method Progression 30 weeks Neurological progression, progression free survival, overall survival.
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.
Trial Locations
- Locations (1)
Neurologische Universitaetsklinik Bonn
🇩🇪Bonn, Germany