NCT01592045

ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

A Comparative Pharmacokinetic and Safety Study of Chimeric Monoclonal Antibody ch14.18 With Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interleukin-2 (IL-2) and Isotretinoin in High Risk Neuroblastoma Patients Following Myeloablative Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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 \[NCI\]).

Detailed description

This is a multi-center, randomized, open-label, two-sequence, cross-over study for eligible subjects with high-risk neuroblastoma to assess the comparability of ch14.18 manufactured with UTC drug product and ch14.18 manufactured with NCI drug product. Subjects will be randomly allocated to receive ch14.18 manufactured by UTC or NCI during Courses 1 and 2 followed by ch14.18 manufactured by other manufacturer (UTC or NCI) during Courses 3, 4, and 5.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-05-04
• Last updated: 2015-09-23
• Results posted: 2015-09-23

Locations

13 sites across 1 country: United States