rhEndostatin Protein Involving Pediatric Patients With Cancer
The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation of new blood vessel factors, and to perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells (cells in the body that help the tumor build more blood vessels).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Safety, Pharmacokinetic and Pharmacodynamic Study of rhEndostatin Protein Administered by Continuous Intravenous Infusion to Pediatric Patients With Cancer|
- To assess the safety of rhEndostatin protein in pediatric patients with recurrent or progressive cancer that is measurable and that is refractory to standard therapies. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To determine how much of the drug stays in the blood of patients (pharmacokinetics)and to evaluate tumor response after treatment with rhEndostatin on this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- Patients will receive rhEndostatin intravenously continuously for 28 days and will be enrolled into one of 2 dosing groups.
- During the initial course of treatment, subjects will be evaluated for treatment-related side effects. If there are no side effects or disease progression, they may receive an additional 28 days of continuous rhEndostatin.
- During the infusion of rhEndostatin, blood samples will be collected before, during and after the drug is given to determine how much of the drug stays in the blood. Blood will be drawn on days 1, 8, 22 and 29. After the completion of therapy, a blood sample will be collected at least 3 days after to determine the level (if any) of rhEndostatin still in the patients blood.
- Blood and/or urine samples to determine immune reactions against rhEndostatin as well as molecules that tumors may use to stimulate new blood vessel growth will be drawn at the start of the study as well as after the completion of each 28-day cycle and completion of the study.
- When a tumor-specific marker that can be used to monitor the status of the disease is present, blood samples for the measurement marker will be obtained at the start of the study as well as after each cycle.
- Appropriate imaging studies (MRI, CT scan, x-ray) will be done after the completion of the first two 28-day cycles and then at the completion of each 28-day cycle for the duration of therapy.
- Treatment will be continued for 1 year and may be extended if the drugs are well tolerated and disease progression has not occured.
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Mark W Kieran, MD,PhD||Dana-Farber Cancer Institute|