Vorinostat in Children

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

March 24, 2017

Study Completion Date

March 24, 2017

Conditions
Children With Relapsed Solid Tumor, Lymphoma or Leukemia
Interventions
DRUG

zolinza/vorinostat

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.

Trial Locations (10)

20246

Department of Pediatric Oncology and Hematology University Hospital Eppendorf (UKE), Hamburg

28205

Prof. Hess Childrens's Hospital, Pediatric Oncology and Hematology, Bremen

30625

University Children's Hospital, Pediatric Oncology and Hematology, MHH, Hanover

45122

University Childrens's Hospital, Pediatric Oncology and Hematology, Essen

48149

Department of Pediatric Oncology and Hematology University Children's Hospital, Münster

50937

University Children's Hospital, Pediatric Oncology and Hematology, Cologne

69198

Clinic for Pediatric Oncology, Hematology, Immunology and Clinical Cooperation Unit Pediatric Oncology, Heidelberg

79106

University Children's Hospital, Clinic IV, Freiburg im Breisgau

86156

Childrens's Hospital, Pediatric Oncology and Hematology, Augsburg

07743

University Childrens's Hospital, Pediatric Oncology and Hematology, Jena

All Listed Sponsors
collaborator

University Hospital Heidelberg

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

National Center for Tumor Diseases, Heidelberg

OTHER

NCT01422499 - Vorinostat in Children | Biotech Hunter | Biotech Hunter