The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety of the study drug and its effect on the disease will also be studied.
Pharmacokinetic (PK) testing of EZN-2208, will be performed for patients who volunteer. PK testing measures the amount of a drug in the body at different time points.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Experimental
Lia Gore, MD
Aurora, Colorado, United States
Suzanne Shusterman, MD
Boston, Massachusetts, United States
Rochelle Bagatell, MD (Principal Investigator)
Philadelphia, Pennsylvania, United States
Jodi Muscal, MD
Houston, Texas, United States
Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.
The study will measure incidence, severity and duration of adverse events graded by NCI CTCAE during first cycle of therapy to determine the MTD. A Phase 2 Dose will be recommended by study investigators after considering the frequency and severity of adverse events and the ability to maintain dose schedule
Time frame: 2 years
Assess evidence of tumor response activity of EZN-2208
An evaluation of objective Tumor response by radiographic scans will be performed every two cycles following the criteria of RECIST 1.1.
Time frame: 2 years
Evaluate the safety and tolerability of EZN-2208
The incidence, severity and duration of adverse events graded by NCI CTCAE during all cycles of therapy will be used to assess safety and tolerability.
Time frame: 2 years
Assess the PK profile of EZN-2208
The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples.
Time frame: 2 years
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