NCT01422499|CompletedPhase 1/2DMC
Vorinostat in Children
Phase I/II Intra-patient Dose Escalation Study of Vorinostat in Children With Relapsed Solid Tumor, Lymphoma or Leukemia
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Sponsor study identifier
interventional
50
1 country
10
Study Start
March 2012
Actual (reported)Primary Completion
March 24, 2017
Actual (reported)Study Completion
March 24, 2017
Actual (reported)The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology, to determine pharmacokinetics of vorinostat in children, determine response rates, safety and feasibility.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 24, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2011
Actual (reported)August 24, 2011
Actual (reported)March 2012
Actual (reported)March 24, 2017
Actual (reported)March 24, 2017
Actual (reported)To determine a safe dose recommended (SDR) for the routine application of oral vorinostat (involving dose escalation) in children and adolescents (3-18 years) with relapsed/refractory solid tumor, lymphoma or leukemia.
A SDR is defined as the highest dose with no ≥ grade 3 toxicity according to CTC criteria (Dose Limiting Toxicity) in no more than 1/50 patient in this study. Dose Limiting Toxicity (DLT) is defined as any grade 3 or 4 toxicity according the CTCAE version 4.0 and judged by the investigator as definitely, probably or possibly related to the study drug. However, all DLTs will be subject to a second assessment by the Coordinating Investigator or a designated person.
After finding the individual MTD this dose will be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.
pharmacokinetics
d 8, when maximum tolerated dose (MTD) ist reached and after 3 months treatment at MTD
antitumor effectiveness
three months after start of treatment with the individual MTD
association of the histone deacetylase (HDAC)-inhibiting activity with the dose administered, toxicity, and treatment response
d8, after reaching the MTD and after 3 months treatment at MTD
safety
during dose escalation and during 3 months treatment at MTD every week; during prolongation of treatment and follow-up every second week
duration of response in responding patients
every 3 months until progression of tumor
orally once per day (suspension of 50mg/ml or capsules of 100 mg vorinostat); starting dose will be 180 mg/m²/d; escalated with increments of 50 mg/m²/d every two weeks until dose limiting toxicity (grade 3 or 4 toxicity according to CTC) occurs or up to a maximum dose of 580 mg/m²/d; This dose will then be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.
Clinic for Pediatric Oncology, Hematology, Immunology and Clinical Cooperation Unit Pediatric Oncology
Heidelberg, Baden-Wurttemberg, 69198, Germany
Childrens's Hospital, Pediatric Oncology and Hematology
Augsburg, 86156, Germany
Prof. Hess Childrens's Hospital, Pediatric Oncology and Hematology
Bremen, 28205, Germany
University Children's Hospital, Pediatric Oncology and Hematology
Cologne, 50937, Germany
University Childrens's Hospital, Pediatric Oncology and Hematology
Essen, 45122, Germany
University Children's Hospital, Clinic IV
Freiburg im Breisgau, 79106, Germany
van Tilburg CM, Milde T, Witt R, Ecker J, Hielscher T, Seitz A, Schenk JP, Buhl JL, Riehl D, Fruhwald MC, Pekrun A, Rossig C, Wieland R, Flotho C, Kordes U, Gruhn B, Simon T, Linderkamp C, Sahm F, Taylor L, Freitag A, Burhenne J, Foerster KI, Meid AD, Pfister SM, Karapanagiotou-Schenkel I, Witt O. Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma, or leukemia. Clin Epigenetics. 2019 Dec 10;11(1):188. doi: 10.1186/s13148-019-0775-1.
Witt O, Milde T, Deubzer HE, Oehme I, Witt R, Kulozik A, Eisenmenger A, Abel U, Karapanagiotou-Schenkel I. Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia. Klin Padiatr. 2012 Oct;224(6):398-403. doi: 10.1055/s-0032-1323692. Epub 2012 Aug 22.
Olaf Witt, Prof. Dr.
University Hospital Heidelberg and German Cancer Research Center (DKFZ)
50 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2011
First Posted
August 24, 2011
Study Start
March 2012
Actual (reported)Primary Completion
Study of Vorinostat Plus Melphalan and Prednisone (Zmp) in Advanced, Refractory Multiple Myeloma Patients
Contact the study team to confirm eligibility.
Department of Pediatric Oncology and Hematology University Hospital Eppendorf (UKE)
Hamburg, 20246, Germany
University Children's Hospital, Pediatric Oncology and Hematology, MHH
Hanover, 30625, Germany
University Childrens's Hospital, Pediatric Oncology and Hematology
Jena, 07743, Germany
Department of Pediatric Oncology and Hematology University Children's Hospital
Münster, 48149, Germany
March 24, 2017
Actual (reported)Study Completion
March 24, 2017
Actual (reported)Last Updated
April 11, 2018
Record last verified: 2018-04
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