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

NCT00029523 | Completed Phase 4

• 1 other identifier: SKY0101-010
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 23

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.

Conditions

Meningeal Neoplasms

Keywords

neoplastic; meningitis; cerebrospinal fluid; CSF; meningeal; meninges; CNS; Leptomeningeal Neoplasms

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• 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

Interventions

Intrathecal (injected into the spinal fluid) DepoCyt DRUG

Intrathecal methotrexate DRUG

Intrathecal cytarabine (also known as ara-C) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (23)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

University of Southern California, Norris Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Hospital, Anschutz Cancer Pavilion

Denver, Colorado, 80010, United States

Location

Georgetown University Medical Center Hematology/Oncology

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory Clinic, Department of Neurosurgery

Atlanta, Georgia, 30322, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center, Dept. of Hematology/Oncology

Maywood, Illinois, 60153, United States

Location

Beth Israel Deaconess Medical Center Dept. of Neurology

Boston, Massachusetts, 02215, United States

Location

Park Nicollet Institute, Oncology Research Program

Minneapolis, Minnesota, 55416, United States

Location

JFK Neuroscience Institute

Edison, New Jersey, 08820, United States

Location

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

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University Hospital of Cleveland

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78284, United States

Location

University of Utah, Hunsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E0V9, Canada

Location

Toronto Sunnybrook Regional Cancer Center

Toronto, Ontario, M4N3M5, Canada

Location

Related 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.

  PMID: 10589750 BACKGROUND

• 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.

  PMID: 10506606 BACKGROUND

MeSH Terms

Conditions

Meningeal Neoplasms; Meningitis

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ahmet Tutuncu, MD, PhD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 15, 2002
• First Posted: January 16, 2002
• Study Start: April 1, 2001
• Study Completion: November 1, 2004
• Last Updated: February 28, 2007

Record last verified: 2007-02

Locations

CA (2); US (21)