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Erythropoietin Spinal Cord Compression Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220675
Recruitment Status : Terminated (Insufficient accrual)
First Posted : September 22, 2005
Last Update Posted : May 22, 2008
Ortho Biotech, Inc.
Information provided by:
Sunnybrook Health Sciences Centre

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

Condition or disease Intervention/treatment Phase
Nerve Compression Syndromes Drug: Erythropoietin infusion Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Primary Outcome Measures :
  1. Overall survival
  2. Recovery of ambulation
  3. Deep vein thrombosis rate post-treatment

Secondary Outcome Measures :
  1. The time to regain ambulation
  2. Duration of ambulatory function
  3. Health-related quality of life (HRQOL, prevalence of TVE at the time of randomization

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00220675

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Canada, Ontario
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, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Ortho Biotech, Inc.
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Principal Investigator: Andrew Loblaw, MD MSc Sunnybrook & Women's College Health Science Centre
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Responsible Party: Dr. Andrew Loblaw, Sunnybrook & Women's College Health Sciences Identifier: NCT00220675    
Other Study ID Numbers: 9427-T0926-28C
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008
Keywords provided by Sunnybrook Health Sciences Centre:
Malignant extradural spinal cord compression
Additional relevant MeSH terms:
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Spinal Cord Compression
Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Epoetin Alfa