Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165373
Status:
TERMINATED
Last Update Posted:
2007-12-28
First Post:
2005-09-09
Brief Title:
rhEndostatin Protein Involving Pediatric Patients With Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Safety Pharmacokinetic and Pharmacodynamic Study of rhEndostatin Protein Administered by Continuous Intravenous Infusion to Pediatric Patients With Cancer
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 antibodiesusing 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
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None