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

Sponsor:	Pacira Pharmaceuticals, Inc
Information provided by:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00029523

Purpose

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.

Condition	Intervention	Phase
Meningeal Neoplasms	Drug: Intrathecal (injected into the spinal fluid) DepoCyt Drug: Intrathecal methotrexate Drug: Intrathecal cytarabine (also known as ara-C)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Meningitis

Drug Information available for: Methotrexate Cytarabine hydrochloride Cytarabine

U.S. FDA Resources

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	April 2001
Estimated Study Completion Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029523

Show 23 Study Locations

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Investigators

Study Director:

Ahmet Tutuncu, MD, PhD

Pacira Pharmaceuticals, Inc

More Information

Publications:

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.

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.

Study ID Numbers:	SKY0101-010
Study First Received:	January 15, 2002
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00029523 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:

neoplastic
meningitis
cerebrospinal fluid
CSF

meningeal
meninges
CNS
Leptomeningeal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Meningeal Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Central Nervous System Neoplasms
Reproductive Control Agents
Meningitis
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Methotrexate

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Cytarabine
Nervous System Neoplasms
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Central Nervous System Infections
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 18, 2010