Know Cancer

forgot password

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

Phase 2/Phase 3
19 Years
Not Enrolling
Nerve Compression Syndromes

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Andrew Loblaw, MD MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook & Women's College Health Science Centre


Canada: Health Canada

Study ID:




Start Date:

August 2005

Completion Date:

July 2007

Related Keywords:

  • Nerve Compression Syndromes
  • Malignant extradural spinal cord compression
  • Erythropoietin
  • Neuroprotectant
  • Radiotherapy
  • Palliation
  • Nerve Compression Syndromes
  • Charcot-Marie-Tooth Disease
  • Hereditary Sensory and Motor Neuropathy
  • Spinal Cord Compression