NCT01563614

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leptomeningeal Metastasis From Malignant Melanoma

Interventions

Type	Name	Description
RADIATION	Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)	Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
DRUG	Lomustine	Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
DRUG	Liposomal cytarabine	Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-03-27
• Last updated: 2016-04-19

Locations

1 site across 1 country: Germany