Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis
Sponsor study identifier
Secondary identifiers
interventional
28
1 country
8
Study Start
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2003
Actual (reported)Study Completion
Not reported
Date not reportedRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this treatment regimen.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 11, 2000
Actual (reported)November 2000
Date type not reportedThis date has not been verified as actual or estimated.
January 27, 2003
Actual (reported)May 2003
Actual (reported)Toxicities of IT administered busulfan in children and adolescents with refractory CNS malignancies
Maximum tolerated dose of IT administered busulfan
Serum and CSF pharmacokinetics of IT administered busulfan
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Gururangan S, Petros WP, Poussaint TY, Hancock ML, Phillips PC, Friedman HS, Bomgaars L, Blaney SM, Kun LE, Boyett JM. Phase I trial of intrathecal spartaject busulfan in children with neoplastic meningitis: a Pediatric Brain Tumor Consortium Study (PBTC-004). Clin Cancer Res. 2006 Mar 1;12(5):1540-6. doi: 10.1158/1078-0432.CCR-05-2094.
Sri Gururangan, MD
Duke University
28 participants (actual enrollment reported by the registry).
First Submitted
September 11, 2000
First Posted
January 27, 2003
Study Start
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
Study of Busulfan for Refractory Central Nervous System (CNS) Tumors
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Houston, Texas, 77030, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105, United States
Primary Completion
May 2003
Actual (reported)Last Updated
October 7, 2009
Record last verified: 2009-10
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Source: ClinicalTrials.gov.
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