Lack of additional funding; patients (3) no longer receiving intervention.
A Phase II Study of Intraventricular Methotrexate With Systemic Topotecan and Cyclophosphamide in Children With Recurrent or Progressive Malignant Brain Tumors
Sponsor study identifier
interventional
3
1 country
1
Study Start
February 2016
Actual (reported)Primary Completion
December 9, 2019
Actual (reported)Study Completion
December 9, 2019
Actual (reported)The purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 9, 2019
Actual (reported)Click 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.
February 2016
Actual (reported)February 11, 2016
Actual (reported)February 17, 2016
Actual (reported)December 9, 2019
Actual (reported)December 9, 2019
Actual (reported)Tumor response
MRI response
6 months
Toxicity of chemotherapy regimen (topotecan and cyclophosphamide)
6 months
IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide
IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide
To be administered in conjunction with methotrexate
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
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.
Slavc I, Schuller E, Czech T, Hainfellner JA, Seidl R, Dieckmann K. Intrathecal mafosfamide therapy for pediatric brain tumors with meningeal dissemination. J Neurooncol. 1998 Jun-Jul;38(2-3):213-8. doi: 10.1023/a:1005940405165.
Ziad Khatib, MD
Nicklaus Children's Hospital
3 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2016
First Posted
February 17, 2016
Study Start
February 2016
Actual (reported)To be administered in conjunction with methotrexate and topotecan
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Yoshimura J, Nishiyama K, Mori H, Takahashi H, Fujii Y. Intrathecal chemotherapy for refractory disseminated medulloblastoma. Childs Nerv Syst. 2008 May;24(5):581-5. doi: 10.1007/s00381-007-0538-8. Epub 2007 Dec 5.
Sandberg DI, Solano J, Petito CK, Mian A, Mou C, Koru-Sengul T, Gonzalez-Brito M, Padgett KR, Luqman A, Buitrago JC, Alam F, Wilkerson JR, Crandall KM, Kuluz JW. Safety and pharmacokinetic analysis of methotrexate administered directly into the fourth ventricle in a piglet model. J Neurooncol. 2010 Dec;100(3):397-406. doi: 10.1007/s11060-010-0210-0. Epub 2010 May 4.
Sandberg DI, Crandall KM, Koru-Sengul T, Padgett KR, Landrum J, Babino D, Petito CK, Solano J, Gonzalez-Brito M, Kuluz JW. Pharmacokinetic analysis of etoposide distribution after administration directly into the fourth ventricle in a piglet model. J Neurooncol. 2010 Mar;97(1):25-32. doi: 10.1007/s11060-009-9998-x. Epub 2009 Aug 18.
Sandberg DI, Crandall KM, Petito CK, Padgett KR, Landrum J, Babino D, He D, Solano J, Gonzalez-Brito M, Kuluz JW. Chemotherapy administration directly into the fourth ventricle in a new piglet model. Laboratory Investigation. J Neurosurg Pediatr. 2008 May;1(5):373-80. doi: 10.3171/PED/2008/1/5/373.
Primary Completion
December 9, 2019
Actual (reported)Study Completion
December 9, 2019
Actual (reported)Last Updated
January 10, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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