drugset / Trial / NCT01014767

Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

NCT01014767

Phase 3 Terminated 27 enrolled Tufts Medical Center
RandomizedSingle-groupOpen-labelTreatment

Summary

This is a "tissue banking and data review" research study that also has a "clinical" research part: * The goal of the tissue banking part of this study is to store tissue in a research tissue bank by the International Society for Pediatric Oncology (SIOP) at an international reference center for choroid plexus tumors. The tissue will be used in future research related to cancer. * The goal of the data review part of this study is to collect information from the medical records of patients with choroid plexus tumors, and to store the information in SIOP databases for use in future research related to cancer. * The goal of this clinical research study is to compare 4 chemotherapy treatments for choroid plexus tumors. The safety and level of effectiveness of these study treatments will be compared and studied. The study drugs include different combinations of etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin, cisplatin, dactinomycin, temozolomide, and irinotecan.

Timeline

Start
2009-11
Primary completion
2013-10
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 350 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 1 g Intravenous
Subject Dactinomycin Protein / enzyme biologic 45 ug/kg Intravenous
Subject Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Methotrexate Small molecule 5 g Intravenous
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Background Leucovorin Small molecule Intravenous