Nerve Compression SyndromesPhase 2/3NCT00220675
Erythropoietin Spinal Cord Compression Randomized Trial
A Phase 2/3 study testing Erythropoietin infusion in people with Nerve Compression Syndromes, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
Trial summary
To determine whether erythropoietin, steroids and radiotherapy is safe and feasible to administer to patients with malignant spinal cord compression. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nerve Compression Syndromes
- What is being tested?
- Erythropoietin infusion
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2005to Jul 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
London Regional Health Science Center
London, Ontario
Ottawa Regional Cancer Center
Ottawa, Ontario
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, M4N 3M5
About this study
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
To determine whether erythropoietin, steroids and radiotherapy is safe and feasible to administer to patients with malignant spinal cord compression.
Read the 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
- Being tested
- Erythropoietin infusion
- Keywords
- Malignant extradural spinal cord compression, Erythropoietin, Neuroprotectant, Radiotherapy, Palliation
- Medical subject headings
- Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin infusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Recovery of ambulation
Deep vein thrombosis rate post-treatment
Secondary outcomes (3)
The time to regain ambulation
Duration of ambulatory function
Health-related quality of life (HRQOL, prevalence of TVE at the time of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Compression SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Investigators
- Andrew Loblaw, MD MSc, Principal investigator, Sunnybrook & Women's College Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220675
- Sponsor's protocol ID
- 9427-T0926-28C
- Status last verified
- May 2008
- First submitted
- 20 Sep 2005
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00220675
- Acronym / sponsor ID
- 9427-T0926-28C
- Conditions
- Nerve Compression Syndromes
- Keywords
- Malignant extradural spinal cord compression, Erythropoietin, Neuroprotectant, Radiotherapy, Palliation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Aug 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythropoietin infusion | Drug | – |
Primary outcome
Overall survival
Recovery of ambulation
Deep vein thrombosis rate post-treatment
3 secondary outcomes
The time to regain ambulation
Duration of ambulatory function
Health-related quality of life (HRQOL, prevalence of TVE at the time of randomization
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Loblaw, MD MSc principal investigator
Sunnybrook & Women's College Health Science Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Erythropoietin infusion in people with Nerve Compression Syndromes, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.