Status:
COMPLETED
Vorinostat in Children
Lead Sponsor:
National Center for Tumor Diseases, Heidelberg
Collaborating Sponsors:
University Hospital Heidelberg
Merck Sharp & Dohme LLC
Conditions:
Children With Relapsed Solid Tumor, Lymphoma or Leukemia
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
Relapsed or progressive solid tumors and leukemias have a very poor prognosis in children despite intense multimodal treatment protocols involving polychemotherapy, surgery, and radiation. Therefore, ...
Eligibility Criteria
Inclusion
- Children and adolescents (3-18 years) with relapsed or therapy-refractory solid tumor, lymphoma or leukemia following standard first-line or relapse protocols in pediatric oncology
- Diagnosis confirmed by one of the Pathological, Radiological or Study Reference Centers recognized by the GPOH
- No other simultaneous anti-neoplastic treatment or radiation during the study and 1 months before enrolment
- Sufficient general condition (Lansky Score \>50%)
- Life expectancy \> 3 months
- Liver enzymes (ALT or AST) \< 5x upper limit of normal reference value, bilirubin and creatinine \< 3x upper limit of normal reference value
- Solid tumors: leukocytes \> 2000/µl, thrombocytes \> 50.000/µl and adequate bone marrow function to permit evaluations of hematopoietic toxicity
- No CTC grade 3 or 4 toxicity from previous treatments
- Normal ECG
- Written informed consent of the legal representatives and the patient if the patient is able to understand the study situation and to give consent (must be available before enrolment in the trial)
- Women with childbearing potential agree to use adequate contraception or to abstain from heterosexual activity throughout the study, starting with Visit 1.
- Sexually active male patient agrees to use an adequate method of contraception for the duration of the study
- Solid tumors: measurable disease activity according to RECIST criteria
Exclusion
- History of deep vein thrombosis or pulmonary embolism
- Pregnancy and lactation
- Patient with concomitant treatments and/or anti-neoplastic treatment such as chemotherapy, immune therapy, and differentiation therapy, other targeted therapy, radiation. The use of valproic acid as prior antiepileptic therapy is allowed with a 30-day washout period.
- Prior exposure to Histone Deacetylase Inhibitors
- Known active HBV, HCV or HIV infection
- Patient with concomitant treatments such as amber \[Hypericum perforatum\], plant extracts, vitamins, and other anti-oxidative compounds
- Participation in other clinical trials or observation period of competing trials, respectively
- Patient is unable to swallow vorinostat suspension or capsules
- Patient on coumarin-derivative anticoagulants
- Any other medication which could accentuate known dose-dependent adverse effects of the study drug, for instance bone marrow depression or QT-prolongation
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01422499
Start Date
March 1 2012
End Date
March 24 2017
Last Update
April 11 2018
Active Locations (10)
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1
Clinic for Pediatric Oncology, Hematology, Immunology and Clinical Cooperation Unit Pediatric Oncology
Heidelberg, Baden-Wurttemberg, Germany, 69198
2
Childrens's Hospital, Pediatric Oncology and Hematology
Augsburg, Germany, 86156
3
Prof. Hess Childrens's Hospital, Pediatric Oncology and Hematology
Bremen, Germany, 28205
4
University Children's Hospital, Pediatric Oncology and Hematology
Cologne, Germany, 50937