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

NCT ID: NCT00029523

Last Updated: 2007-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2004-11-30

Brief Summary

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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

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Conditions

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Meningeal Neoplasms

Keywords

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neoplastic meningitis cerebrospinal fluid CSF meningeal meninges CNS Leptomeningeal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Intrathecal (injected into the spinal fluid) DepoCyt

Intervention Type DRUG

Intrathecal methotrexate

Intervention Type DRUG

Intrathecal cytarabine (also known as ara-C)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ahmet Tutuncu, MD, PhD

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

University of Southern California, Norris Cancer Center

Los Angeles, California, United States

Site Status

University of Colorado Hospital, Anschutz Cancer Pavilion

Denver, Colorado, United States

Site Status

Georgetown University Medical Center Hematology/Oncology

Washington D.C., District of Columbia, United States

Site Status

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory Clinic, Department of Neurosurgery

Atlanta, Georgia, United States

Site Status

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

Rush Cancer Institute

Chicago, Illinois, United States

Site Status

Loyola University Medical Center, Dept. of Hematology/Oncology

Maywood, Illinois, United States

Site Status

Beth Israel Deaconess Medical Center Dept. of Neurology

Boston, Massachusetts, United States

Site Status

Park Nicollet Institute, Oncology Research Program

Minneapolis, Minnesota, United States

Site Status

JFK Neuroscience Institute

Edison, New Jersey, United States

Site Status

Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Case Western Reserve University Hospital of Cleveland

Cleveland, Ohio, United States

Site Status

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

University of Utah, Hunsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Toronto Sunnybrook Regional Cancer Center

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 10589750 (View on PubMed)

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. doi: 10.1200/JCO.1999.17.10.3110.

Reference Type BACKGROUND
PMID: 10506606 (View on PubMed)

Other Identifiers

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SKY0101-010

Identifier Type: -

Identifier Source: org_study_id