Status:
TERMINATED
Erythropoietin Spinal Cord Compression Randomized Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Nerve Compression Syndromes
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00220675
Start Date
August 1 2005
End Date
July 1 2007
Last Update
May 22 2008
Active Locations (3)
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1
London Regional Health Science Center
London, Ontario, Canada
2
Ottawa Regional Cancer Center
Ottawa, Ontario, Canada
3
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada, M4N 3M5