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

Tracking Information

First Received Date ^ICMJE

January 15, 2002

Last Updated Date

February 27, 2007

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00029523 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meningeal Neoplasms

Intervention ^ICMJE

Drug: Intrathecal (injected into the spinal fluid) DepoCyt
Drug: Intrathecal methotrexate
Drug: Intrathecal cytarabine (also known as ara-C)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia)
Diagnosed with neoplastic meningitis
If female, not pregnant and will not become pregnant while on-study
No other experimental therapy within 21 days of participation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00029523

Responsible Party

Study ID Numbers ^ICMJE

SKY0101-010

Study Sponsor ^ICMJE

Pacira Pharmaceuticals, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ahmet Tutuncu, MD, PhD

Pacira Pharmaceuticals, Inc

Information Provided By

Pacira Pharmaceuticals, Inc

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP