Clinical Trial: DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
Brief Summary: The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.
Detailed Summary:
Sponsor: Pacira Pharmaceuticals, Inc
Current Primary Outcome: Progression-free survival, defined as the time to neurological progression or death
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to neurological progression;
- Survival (all-cause and meningeal disease-specific)
- Frequency of improvement in pre-existing meningeal-disease related neurological deficits
- Karnofsky Performance Scores (KPS)
- Quality of life
- Cytological response rate
- Overall safety profile
Original Secondary Outcome: Same as current
Information By: Pacira Pharmaceuticals, Inc
Dates:
Date Received: January 15, 2002
Date Started: April 2001
Date Completion: November 2004
Last Updated: February 27, 2007
Last Verified: February 2007