Erythropoietin Spinal Cord Compression Randomized Trial

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa

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