Erythropoietin Spinal Cord Compression Randomized Trial

NCT ID: NCT00220675

Last Updated: 2008-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-07-31

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.

Conditions

Nerve Compression Syndromes

Keywords

Malignant extradural spinal cord compression; Erythropoietin; Neuroprotectant; Radiotherapy; Palliation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Erythropoietin infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults (> 18 years old) with histopathologically confirmed cancer
• Patients unable to ambulate independently due to paraparesis or paraplegia from malignant epidural spinal cord compression (categories 2, 3, 4 in Appendix B)
• Radiotherapy offered for treatment of cord compression using 2000cGy in 5 fractions
• Informed consent signed
• Females subjects must be post-menopausal or surgically incapable of childbearing potential, must be practicing an acceptable method of birth control (i.e., hormonal contraceptives, intrauterine device or barrier and spermicide)

Exclusion Criteria

• Uncontrolled hypertension (systolic pressure > 160 mmHg, diastolic > 100 mmHg) or unstable cardiovascular disease
• Previous DVT/PE or arterial embolic event
• Patients with a Hb > 120 g/L or Hct > 40% (for both males & females)
• Patients with potentially curable disease
• Patients with life expectancy < 3 months
• Patients who have received RT that would overlap with the planned treatment field
• Contraindications for MRI scan
• Women who are pregnant, or who intend to become pregnant, or who are nursing
• Patients with known brain metastases; those with a primary diagnosis of melanoma will require confirmation by CT or MRI
• Patients with a history of poorly controlled seizure disorder
• Patients with a known hypersensitivity to mammalian cell-derived products or albumin
• Patients who cannot receive adequate antithrombotic treatment, who have a hypersensitivity to the active antithrombotic substance or any of the product's excipients
• Patients who have participated in another investigational device or drug trial(s), or is receiving other investigational agent(s) within the previous 30 days
• Patients requiring neurosurgical decompression for the malignant spinal cord compression

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Sunnybrook & Women's College Health Sciences

Principal Investigators

Andrew Loblaw, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook & Women's College Health Science Centre

Locations

London Regional Health Science Center

London, Ontario, Canada

Ottawa Regional Cancer Center

Ottawa, Ontario, Canada

Sunnybrook & Women's College Health Science Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

9427-T0926-28C

Identifier Type: -

Identifier Source: org_study_id