NCT00854867

Study to Demonstrate the Safety of WBR Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyte®) Versus Intrathecal Liposomal Cytarabine (DepoCyte®) Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastasis.

Phase I Randomised Multi-centre Study to Demonstrate the Safety of WBRT Concomitant to Intrathecal Liposomal Cytarabine (DepoCyte®) Versus WBRT & Sequential Intrathecal Liposomal Cytarabine (DepoCyte®) for Treatment of STNM With or Without Brain Metastasis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same time as WBRT with giving the drug after WBRT is complete.

Conditions

• Solid Tumour Neoplastic Meningitis
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Whole Brain Radio Therapy (WBRT) with sequential Depocyte
DRUG	Whole brain radiotherapy (WBRT) with concomitant Depocyte

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-03-03
• Last updated: 2014-02-24

Locations

7 sites across 2 countries: Austria, Germany