Erythropoietin Spinal Cord Compression Randomized Trial

NCT00220675 | Terminated Phase 2 DMC

• 1 other identifier: 9427-T0926-28C
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Nerve Compression Syndromes

Keywords

Malignant extradural spinal cord compression; Erythropoietin; Neuroprotectant; Radiotherapy; Palliation

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Erythropoietin infusion DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (3)

London Regional Health Science Center

London, Ontario, Canada

Location

Ottawa Regional Cancer Center

Ottawa, Ontario, Canada

Location

Sunnybrook & Women's College Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Andrew Loblaw, MD MSc

  Sunnybrook & Women's College Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 22, 2008

Record last verified: 2008-05

Locations

CA (3)