ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

DepoCyt Therapy in Patients with Neoplastic Meningitis from Lymphoma or a Solid Tumor

This study is currently recruiting patients.

Sponsored by: SkyePharma
Information provided by: SkyePharma

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 Treatment or 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

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  100

Study start: April 2001

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria


Location and Contact Information

Jeff Miller, BSc      858 625 2414  Ext. 3357    jeffrey_miller@skyepharma.com

Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States; Recruiting
Emily Khoury, RN  602-406-3614    ekhoury@uthscsa.edu 
William Shapiro, MD,  Principal Investigator

California
      University of Southern California, Norris Cancer Center, Los Angeles,  California,  90033,  United States; Not yet recruiting
Traci Babcock, RN  323-865-3945 
Marc C Chamberlain, MD  323-865-0061 
Marc C Chamberlain, MD,  Principal Investigator

      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States; Not yet recruiting
Beth Davis, CRA  510-204-3428    bdavis@salick.com 
David Irwin, MD  510-502-3428 
David Irwin, MD,  Principal Investigator

Colorado
      University of Colorado Hospital, Anschutz Cancer Pavilion, Denver,  Colorado,  80010,  United States; Recruiting
Lisa Robinson, RN  720-848-0667    lisa.robinson@uchsc.edu 
Denise Damek, MD  720-848-2082 
Denise Damek, MD,  Principal Investigator

District of Columbia
      Georgetown University Medical Center Hematology/Oncology, Washington,  District of Columbia,  20007,  United States; Recruiting
Said Baidas, MD  202-687-7320    baidass@gunet.georgetown.edu 
Said Baidas, MD,  Principal Investigator

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States; Recruiting
Shirley Entis, RN  813-979-3951 
Surasak Phuphanich, MD  813-972-8439 
Surasak Phuphanich, MD,  Principal Investigator

      Mayo Clinic, Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Carolyn Bieber, RN  904-953-6824    bieber.carolyn@mayo.edu 
Kurt A Jaeckle, MD  904-953-7233 
Kurt A Jaeckle, MD,  Principal Investigator

Georgia
      Emory Clinic, Department of Neurosurgery, Atlanta,  Georgia,  30322,  United States; Not yet recruiting
Carol Hill, RN  404-778-4907    carol_hill@eushc.org 
Jeffrey Olson, MD  404-778-5770 
Jeffrey Olson, MD,  Principal Investigator

Hawaii
      Straub Clinic and Hospital, Honolulu,  Hawaii,  96813,  United States; Not yet recruiting
Carroll H Mimaki, MSc  808-780-6561    chmimaki@hotmail.com 
Lynn Ashby, MD  808-522-4476    hmsblonde@hotmail.com 
Lynn Ashby, MD,  Principal Investigator

Illinois
      Rush Cancer Institute, Chicago,  Illinois,  60612,  United States; Recruiting
Allan Taaca  312-942-5687    ataaca@rush.edu 
Pamela Khosla, MD,  Principal Investigator

      Loyola University Medical Center, Dept. of Hematology/Oncology, Maywood,  Illinois,  60153,  United States; Not yet recruiting
Lode Swinnen, MD  708-327-3142 
Lode Swinnen, MD,  Principal Investigator

Massachusetts
      Beth Israel Deaconess Medical Center Dept. of Neurology, Boston,  Massachusetts,  02215,  United States; Recruiting
Loretta Barron, RN  617-667-1665 
Eric T Wong, MD  617-667-1665 
Eric T Wong, MD,  Principal Investigator

Minnesota
      Park Nicollet Institute, Oncology Research Program, Minneapolis,  Minnesota,  55416,  United States; Recruiting
Janet Hagen, RN, BSN, OCN  952-993-6705    hagenj@parknicollet.com 
Martin W. Lee, MD  952-993-2754 
Martin W Lee, MD,  Principal Investigator

New Jersey
      JFK Neuroscience Institute, Edison,  New Jersey,  08820,  United States; Recruiting
Susan Fowler, RN, PhD  732-632-1584  Ext. 7000    sfowler@solarishs.org 
Subramanian Hariharan, MD  762-321-7950 
Subramanian Hariharan, MD,  Principal Investigator

North Carolina
      Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Michele Harmon, RN, BSN  336-716-1193    mharmon@wfubmc.edu 
Glenn Lesser, MD  336-716-9527 
Glenn J Lesser, MD,  Principal Investigator

Ohio
      Case Western Reserve University Hospital of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Joan Kolb, RN  216-844-7792 
Stephen Sagar, MD  216-844-7510 
Stephen Sagar, MD,  Principal Investigator

Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States; Not yet recruiting
Frank Lieberman, MD  412-692-2600 
Frank Lieberman, MD,  Principal Investigator

Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States; Not yet recruiting
Paul Moots, MD  615-936-0216    paul.moots@mcmail.vanderbilt.edu 
Paul Moots, MD,  Principal Investigator

Texas
      University of Texas Health Science Center, San Antonio,  Texas,  78284,  United States; Recruiting
Diane Johnson, RN  210-617-5300 
Laura Moreno, RN  210-617-5161    morenolm@uthscsa.edu 
Pamela New, MD,  Principal Investigator

Utah
      University of Utah, Hunsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States; Recruiting
Julia Batten, CANP, MPH  801-585-6456    julia.batten@hsc.utah.edu 
Deborah T Blumenthal, MD  801-585-6456 
Deborah T Blumenthal, MD,  Principal Investigator

Washington
      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States; Recruiting
Cheryl Clark-Weaver, CCRC  206-223-6748    cheryl.weaver@vmmc.org 
Lynne Taylor, MD  206-341-0420 
Lynne Taylor, MD,  Principal Investigator

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E0V9,  Canada; Not yet recruiting
Erna Stiles, RN  204-787-2127    erna.stiles@cancercare.mb.ca 
David D Eisenstat, MD  204-787-1167 
David D Eisenstat, MD,  Principal Investigator

Canada, Ontario
      Toronto Sunnybrook Regional Cancer Center, Toronto,  Ontario,  M4N3M5,  Canada; Recruiting
Cindy Foden, RN  416-480-5846    cindy.foden@tsrcc.on.ca 
Rena Buckstein, MD  416-480-5000 
Rena Buckstein, MD,  Principal Investigator

Study chairs or principal investigators

John Gait, MD,  Director, Pharmacovigilance and Medical Affairs / DepoCyt Medical Monitor   

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
Record last reviewed:  January 2002
Record first received:  January 15, 2002
ClinicalTrials.gov Identifier:  NCT00029523
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act