Vorinostat in Children

Conditions

• Children With Relapsed Solid Tumor, Lymphoma or Leukemia

Eligibility Criteria

Sex

ALL

Age

3 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• zolinza/vorinostat — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 31, 2012

Status verified

Apr 2018

Primary completion

Mar 24, 2017

Completion

Mar 24, 2017

Study Design

Enrollment

50 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Primary Outcome Measure

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. [ Time Frame: 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. ]