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

Meningeal Neoplasms Clinical Trial

Official title:

A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029523
• Other study ID #: SKY0101-010
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2002
• Last updated: February 27, 2007
• Start date: April 2001
• Est. completion date: November 2004

Study information

• Verified date: February 2007
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meningeal Carcinomatosis
• Meningeal Neoplasms
• Meningitis

Intervention

Drug:
• Intrathecal (injected into the spinal fluid) DepoCyt

• Intrathecal methotrexate

• Intrathecal cytarabine (also known as ara-C)

Locations

Country	Name	City	State
Canada	Toronto Sunnybrook Regional Cancer Center	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Emory Clinic, Department of Neurosurgery	Atlanta	Georgia
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Beth Israel Deaconess Medical Center Dept. of Neurology	Boston	Massachusetts
United States	Rush Cancer Institute	Chicago	Illinois
United States	Case Western Reserve University Hospital of Cleveland	Cleveland	Ohio
United States	University of Colorado Hospital, Anschutz Cancer Pavilion	Denver	Colorado
United States	JFK Neuroscience Institute	Edison	New Jersey
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	University of Southern California, Norris Cancer Center	Los Angeles	California
United States	Loyola University Medical Center, Dept. of Hematology/Oncology	Maywood	Illinois
United States	Park Nicollet Institute, Oncology Research Program	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	University of Utah, Hunsman Cancer Institute	Salt lake City	Utah
United States	University of Texas Health Science Center	San Antonio	Texas
United States	Virginia Mason Medical Center	Seattle	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Georgetown University Medical Center Hematology/Oncology	Washington	District of Columbia
United States	Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Glantz MJ, Jaeckle KA, Chamberlain MC, Phuphanich S, Recht L, Swinnen LJ, Maria B, LaFollette S, Schumann GB, Cole BF, Howell SB. A randomized controlled trial comparing intrathecal sustained-release cytarabine (DepoCyt) to intrathecal methotrexate in patients with neoplastic meningitis from solid tumors. Clin Cancer Res. 1999 Nov;5(11):3394-402. — View Citation

Glantz MJ, LaFollette S, Jaeckle KA, Shapiro W, Swinnen L, Rozental JR, Phuphanich S, Rogers LR, Gutheil JC, Batchelor T, Lyter D, Chamberlain M, Maria BL, Schiffer C, Bashir R, Thomas D, Cowens W, Howell SB. Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. J Clin Oncol. 1999 Oct;17(10):3110-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, defined as the time to neurological progression or death
Secondary	Time to neurological progression;
Secondary	Survival (all-cause and meningeal disease-specific)
Secondary	Frequency of improvement in pre-existing meningeal-disease related neurological deficits
Secondary	Karnofsky Performance Scores (KPS)
Secondary	Quality of life
Secondary	Cytological response rate
Secondary	Overall safety profile