Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia - Vorinostat in childre

Phase 1

• Conditions: Relapsed of progressive solid tumor, lymphoma, or leukemia in children and adolescents aage 3-18 years; MedDRA version: 18.0 Level: PT Classification code 10025310 Term: Lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0 Level: HLGT Classification code 10024324 Term: Leukaemias System Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2007-005537-11-DE
• Lead Sponsor: niversity Hospital Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-18
• Study Completion: 2017-03-24
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

? 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 two weeks 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 (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

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? 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 14-day washout period. Washout will be ensured by determining valproic acid plasma level before enrolment.?
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified