Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220675
Status:
TERMINATED
Last Update Posted:
2008-05-22
First Post:
2005-09-20
Brief Title:
Erythropoietin Spinal Cord Compression Randomized Trial
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Recombinant Human Erythropoietin r-HuEPO in the Prevention of Neurologic Sequelae From Malignant Spinal Cord Compression a Multi-Center Placebo-Controlled Phase 2 Randomized Study
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether erythropoietin steroids and radiotherapy is safe and feasible to administer to patients with malignant spinal cord compression
Detailed Description:
For patients with malignant spinal cord compression MSCC who are paraparetic or paraplegic before initiating treatment the current treatment options provide a meager to poor chance of neurologic recovery and the prognosis is guarded Improving the chance of ambulation after treatment for MSCC may dramatically improve patients quality of life decrease days spent in hospital and improve survival Steroids appear to prevent neurologic damage from MSCC and increasing doses appear to have an increasingly protective effect however higher doses are limited by an increasing incidence of serious toxicity
Recombinant human erythropoetin has been shown to improve quality of life in patients with anemia of chronic disease and animal models suggest that r-HuEPO may have a neuroprotective effect Human studies have demonstrated increased CSF concentrations of r-HuEPO after intravenous administration including patients with MESCC Furthermore there is a suggestion that patients treated with intravenous r-HuEPO steroids and RT may recover ambulatory function to a greater degree and faster than patients not treated with r-HuEPO
Ultimately the effect of r-HuEPO in improving neurologic functional and quality of life outcomes will need to be tested in a properly designed large randomized control trial However in order to successfully complete this study in a timely manner a multicenter study will need to be performed There are logistical issues that need to be addressed when setting up a r-HuEPO infusion program
Therefore a multicenter randomized phase 2 study of intravenous r-HuEPO steroids and RT will allow the investigators to address three issues i confirm that the logistical issues at each center can be addressed ii confirm in a larger cohort of patients whether the encouraging neurologic outcomes seen in the preliminary study can be replicated across different settings when compared with a randomized control group iii ensure the safety of EPO in this population including overall survival and incidence of subsequent TVEs with and without EPO
Recombinant human erythropoetin has been shown to improve quality of life in patients with anemia of chronic disease and animal models suggest that r-HuEPO may have a neuroprotective effect Human studies have demonstrated increased CSF concentrations of r-HuEPO after intravenous administration including patients with MESCC Furthermore there is a suggestion that patients treated with intravenous r-HuEPO steroids and RT may recover ambulatory function to a greater degree and faster than patients not treated with r-HuEPO
Ultimately the effect of r-HuEPO in improving neurologic functional and quality of life outcomes will need to be tested in a properly designed large randomized control trial However in order to successfully complete this study in a timely manner a multicenter study will need to be performed There are logistical issues that need to be addressed when setting up a r-HuEPO infusion program
Therefore a multicenter randomized phase 2 study of intravenous r-HuEPO steroids and RT will allow the investigators to address three issues i confirm that the logistical issues at each center can be addressed ii confirm in a larger cohort of patients whether the encouraging neurologic outcomes seen in the preliminary study can be replicated across different settings when compared with a randomized control group iii ensure the safety of EPO in this population including overall survival and incidence of subsequent TVEs with and without EPO
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