Study of EZN-2208 Pediatric Patients With Solid Tumors

A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: EZN-2208

Detailed Description

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
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Lia Gore, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Suzanne Shusterman, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Rochelle Bagatell, MD (Principal Investigator)
  • Texas
    • Houston, Texas, United States, 77030
      • Jodi Muscal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with histologic verification of malignancy at original diagnosis or relapse.
• Measurable or evaluable disease
• Karnofsky score more or equal to 50 for patients >16 years of age and Lansky score more or equal to 50 for patients <16 years of age
• Patients previously treated with irinotecan will be eligible for this study if they have not had documented progressive disease during treatment with an irinotecan-containing regimen.
• Adequate hematologic, hepatic, coagulation, renal, and metabolic function

Exclusion Criteria:

• Pregnant or breast feeding patients will not be enrolled in this study
• Patients who are currently receiving other anticancer agents
• Patients who have an uncontrolled infection
• Patients requiring cytochrome P450 3A4 enzyme inducing or inhibiting agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EZN-2208; Cytotoxic Agent	Drug: EZN-2208; Experimental; Other Names: PEG-SN38

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	2 years

Collaborators and Investigators

• Sponsor: Enzon Pharmaceuticals, Inc.
• Investigators: Study Chair: Rochelle Bagatell, MD, Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 29, 2022
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Patients with non-CNS or CNS tumors; Pediatric patients with Relapsed/Refractory Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: EZN-2208-05