Effect of Samarium on the Relief of Pain Due to Vertebral Metastases

NCT00374751 | Completed Phase 1 DMC

• 1 other identifier: NYM-354
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance. The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.

Conditions

Cancer; Metastasis; Pain

Keywords

Samarium; Kyphoplasty; Pain management; Bone metastases; Histologically proven malignancy in the primary site; Radiographic evidence of bone metastasis; Significant pain equal or more than score 5; Karnofsky Performance status >40; The patient must sign a study specific informed consent

Outcome Measures

Primary Outcomes (1)

• To determine the effect of intravertebral injection of Samarium on the relief of pain

  Measuring the pain by the Visual Analogue Scale

  6 months

Study Arms (1)

Samarium (153SM)

EXPERIMENTAL

Injection of Samarium (153SM)

Drug: Samarium (153SM)

Interventions

Samarium (153SM) DRUG

The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.

Samarium (153SM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be 18 years of age or older
• The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung)
• The patient must have a radiographic evidence of bone metastasis, and this must have been performed within 8 weeks prior to enrollment in the study. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans, magnetic resonance imaging, and PET-CT scans.
• The patient must have an intact anterior wall of spinal canal
• The patient must have significant pain (score 6 or above,)which appears to be related to the radiographically documented metastatic vertebra(e) in concern, as measured by the "Visual Analog Scale"
• The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty operation
• Karnofsky Performance status \>40
• Expected life expectancy of 6 months or greater, as estimated by the physician in charge.
• The patient must sign a study specific informed consent prior to enrollment

You may not qualify if:

• Epidural soft tissue component
• Patients with vertebral metastases and with clinical or radiographic evidence of spinal cord or cauda equina impingement (effacement) or compression
• Inability to undergo anesthesia
• Hematologic primary malignancies Patients received systemic radiotherapy (89SR or 153SM)within 30 days prior to enrollmen

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Pain; Agnosia

Interventions

Samarium; Samarium-153

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Hani Ashamalla, MD, FCCP

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Radiation Oncology

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2016
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

US (1)