Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors
Although radiation therapy is currently the treatment of choice for most spinal metastases,
radioresistant and recurrent neoplasms remain therapeutic dilemmas. Because of the debility
and shortened life expectancy of patients with spinal metastases, treatment that minimizes
blood loss, convalescence, and immobility is critical. The effectiveness and safety of
intratumoral injection of absolute ethanol in eradicating vertebral hemangiomas and hepatic
metastases suggests that intratumoral ethanol injection may also be effective in treating
vertebral metastases. Since most spinal metastases can now be diagnosed with MRI before
they produce spinal instability, it may be possible to treat them with direct ethanol
infusion while preserving spinal stability. Direct ethanol infusion may prove especially
useful in treating symptomatic patients who have received maximal tolerable radiation doses
to the spinal cord. Unlike radiation, which is limited by total radiation dosage, and
intraarterial alcohol, which precludes multiple treatments by occluding the feeding
arteries, intratumoral ethanol injection can be repeated as necessary to obliterate residual
tumor. The potential neurotoxic effects of ethanol can be avoided by using CT-guidance to
position the needle, by monitoring a test injection with contrast, and by injecting ethanol
slowly and in small volumes. Intratumoral injection of absolute ethanol warrants a clinical
trial because it is minimally invasive, has been effective in treating peripheral
metastases, can be used repeatedly, and does not preclude other types of treatments such as
open surgery.
As well as testing the therapeutic efficacy of intratumoral ethanol for spinal metastasis,
this protocol seeks to elucidate the pathophysiology of pain from spinal metastasis.
Correlation of changes in pain with changes in tumor size and tumor pressure pre- and
post-ethanol injection should indicate the relationship of pain to tumor size and pressure.
A group of 11 patients with vertebral hemangiomas has been treated with intratumoral ethanol
at the NIH. This protocol will accrue patients with vertebral hemangiomas who require
treatment with intratumoral ethanol and will continue the post-treatment evaluation of
patients previously treated with intratumoral ethanol at the NIH.
Observational
N/A
United States: Federal Government
940158
NCT00001417
June 1994
May 2002
Name | Location |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda, Maryland 20892 |