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ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

NCT01592045 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-09-23

Study results available
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Summary

The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).

Conditions

Interventions

BIOLOGICAL

ch14.18 -NCI

25 mg/m\^2/day IV for four consecutive days

BIOLOGICAL

ch14.18-UTC

17.5 mg/m\^2/day IV for four consecutive days

BIOLOGICAL

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5.

BIOLOGICAL

Aldesleukin (IL-2)

Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4.

DRUG

Isotretinoin

Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows: If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily). If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Araz Marachelian, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01592045 on ClinicalTrials.gov