Clinical trial · Interventional
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
Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
NCT01563614CI-TRIAL-00021815terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastasis From Malignant Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS) | Radiation | — | UNRESOLVED |
| Liposomal cytarabine | Drug | — | UNRESOLVED |
| Lomustine | Drug | Lomustine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
- interventionNames
- Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
- Drug: Lomustine
- Drug: Liposomal cytarabine
Primary outcomes (1)
- measure
- Safety/Tolerance
- timeFrame
- 30 weeks
- description
- The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
Secondary outcomes (3)
- measure
- Delay of treatments
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.