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Program suspended and divested
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZN-2208 | Experimental | Cytotoxic Agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZN-2208 | Drug | Experimental |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rochelle Bagatell, MD | Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lia Gore, MD | Aurora | Colorado | 80045 | United States | ||
| Suzanne Shusterman, MD |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C528970 | EZN-2208 |
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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 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Rochelle Bagatell, MD (Principal Investigator) | Philadelphia | Pennsylvania | 19104 | United States |
| Jodi Muscal, MD | Houston | Texas | 77030 | United States |