Erythropoietin Spinal Cord Compression Randomized Trial

Sunnybrook Health Sciences Centre

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Nerve Compression Syndromes

Treatments

Drug: Erythropoietin infusion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00220675

9427-T0926-28C

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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