DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

Phase 4

Completed

• Conditions: Meningeal Neoplasms

• Registration Number: NCT00029523
• Lead Sponsor: Pacira Pharmaceuticals, Inc

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 Description

Not available

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2002-01-15
• Study First Submitted QC: 2002-01-15
• Study First Posted: 2002-01-16
• Study Completion: 2004-11
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-27
• Last Update Posted: 2007-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free survival, defined as the time to neurological progression or death

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Alta Bates Comprehensive Cancer Center; 🇺🇸 Berkeley, California, United States

University of Southern California, Norris Cancer Center; 🇺🇸 Los Angeles, California, United States

University of Colorado Hospital, Anschutz Cancer Pavilion; 🇺🇸 Denver, Colorado, United States

Georgetown University Medical Center Hematology/Oncology; 🇺🇸 Washington, District of Columbia, United States

Mayo Clinic, Jacksonville; 🇺🇸 Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Emory Clinic, Department of Neurosurgery; 🇺🇸 Atlanta, Georgia, United States

Straub Clinic and Hospital; 🇺🇸 Honolulu, Hawaii, United States

Rush Cancer Institute; 🇺🇸 Chicago, Illinois, United States

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