Trebananib in Treating Younger Patients With Relapsed or Refractory Solid Tumors, Including Central Nervous System Tumors
|Central Nervous System Neoplasm Solid Neoplasm||Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Other: Laboratory Biomarker Analysis Other: Pharmacological Study Biological: Trebananib||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of AMG 386, an Angiopoietin Neutralizing Peptibody, in Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors|
- Incidence of adverse events as assessed by the National Cancer Institute (NCI) CTCAE v 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]A descriptive summary of all toxicities will be reported.
- MTD at which fewer than one-third of patients experience dose limiting toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 28 days ]
- Pharmacokinetic (PK) parameters of trebananib [ Time Frame: At baseline, at days 1, 8, 15, and 22 of course 1 ]A descriptive analysis of PK parameters of trebananib will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Changes in vascular permeability relative to baseline as evaluated by MRI in patients with CNS tumors [ Time Frame: Baseline to up to 1 year ]
- Disease response assessed according to RECIST version 1.1 [ Time Frame: Up to 1 year ]Reported descriptively.
- Circulating antiangiogenic protein and Tie2 expressing monocyte levels [ Time Frame: Up to 1 year ]Reported descriptively and will utilize intra-patient variability estimated from two baseline blood samples.
|Study Start Date:||February 2012|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (trebananib)
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesBiological: Trebananib
I. To estimate the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of trebananib (AMG 386) administered as a weekly intravenous infusion to children with recurrent or refractory solid tumors.
II. To determine the tolerability of the solid tumor MTD and/or RP2D of AMG 386 in children with central nervous system (CNS) tumors.
III. To define and describe the toxicities of AMG 386 administered on this schedule.
IV. To characterize the pharmacokinetics and immunogenicity of AMG 386 in children with refractory cancer.
V. To measure changes in vascular permeability relative to baseline, evaluated by magnetic resonance imaging (MRI) perfusion, following AMG 386 administration in pediatric patients with CNS tumors.
I. To preliminarily define the antitumor activity of AMG 386 within the confines of a Phase 1 study.
II. To measure biologic markers of angiogenesis with potential for correlation with disease response.
OUTLINE: This is a dose-escalation study (part 1) followed by a safety and imaging study (part 2).
Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 to 6 months for up to 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538095
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|Principal Investigator:||Sarah Leary||COG Phase I Consortium|