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Vorinostat in Children

NCT01422499 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-04-11

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Center for Tumor Diseases, Heidelberg

    lead OTHER

Principal Investigators

  • Olaf Witt, Prof. Dr. · University Hospital Heidelberg and German Cancer Research Center (DKFZ)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-03-24
Completion
2017-03-24

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422499 on ClinicalTrials.gov