Clinical Trial: Erythropoietin Spinal Cord Compression Randomized Trial

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: To determine whether erythropoietin, steroids and radiotherapy is safe and feasible to administer to patients with malignant spinal cord compression.

Detailed Summary:

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
Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome:

  • Overall survival
  • Recovery of ambulation
  • Deep vein thrombosis rate post-treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The time to regain ambulation
  • Duration of ambulatory function
  • Health-related quality of life (HRQOL, prevalence of TVE at the time of randomization


Original Secondary Outcome: Same as current

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: September 20, 2005
Date Started: August 2005
Date Completion:
Last Updated: May 21, 2008
Last Verified: May 2008