rhEndostatin Protein Involving Pediatric Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00165373|
Recruitment Status : Terminated (Lack of drug supply)
First Posted : September 14, 2005
Last Update Posted : December 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: rhEndostatin||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Safety, Pharmacokinetic and Pharmacodynamic Study of rhEndostatin Protein Administered by Continuous Intravenous Infusion to Pediatric Patients With Cancer|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165373
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Mark W Kieran, MD,PhD||Dana-Farber Cancer Institute|