Erythropoietin Spinal Cord Compression Randomized Trial

This study has been terminated.
(Insufficient accrual)
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00220675
First received: September 20, 2005
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Nerve Compression Syndromes
Drug: Erythropoietin infusion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Overall survival
  • Recovery of ambulation
  • Deep vein thrombosis rate post-treatment

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

Enrollment: 7
Study Start Date: August 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220675

Locations
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.
Investigators
Principal Investigator: Andrew Loblaw, MD MSc Sunnybrook & Women's College Health Science Centre
  More Information

No publications provided

Responsible Party: Dr. Andrew Loblaw, Sunnybrook & Women's College Health Sciences
ClinicalTrials.gov Identifier: NCT00220675     History of Changes
Other Study ID Numbers: 9427-T0926-28C
Study First Received: September 20, 2005
Last Updated: May 21, 2008
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Malignant extradural spinal cord compression
Erythropoietin
Neuroprotectant
Radiotherapy
Palliation

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Nerve Compression Syndromes
Spinal Cord Compression
Central Nervous System Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Nervous System Diseases
Nervous System Malformations
Neurodegenerative Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Polyneuropathies
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014