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

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Collaborator: Mundipharma Research GmbH & Co KG
• Treatments: Cytarabine; Lomustine

Criteria

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