Neoplasm Metastasis Clinical Trial
Official title:
Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors
Tumors of the spine can be described as primary, meaning that the tumor originated from
cells normally found in the spine, or metastatic, cells from another area of the body that
have spread to the spine. Metastatic tumors are more common than primary tumors. Tumors of
the spine can press against the spinal cord and interfere with information traveling down
from the brain to the nerves of the spinal cord. As a result, patients with spinal tumors
can suffer from loss of movement and sensation within areas of the body below the tumor. In
addition, tumors of the spine are typically painful conditions.
Presently, the treatment of choice for spinal tumors is radiation therapy. However, many
tumors of the spine become resistant to radiation therapy. In addition, because the spinal
cord is often so close to the tumor it can be damaged by the radiation.
Absolute (100%) ethanol is commonly known as "alcohol". It is the same kind of alcohol found
in alcoholic beverages. When pure alcohol is injected directly into a tumor it can destroy
cells and blood vessels. Because of this feature, researchers would like to test the
effectiveness of alcohol in treating patients with spinal tumors.
Researchers believe that intratumoral ethanol injection is a treatment worth studying more
closely because it is minimally invasive, has been proven to be an effective treatment for
other types of metastatic tumors, can be used repeatedly, and does not interfere with other
treatments such as surgery.
In addition to testing the effectiveness of intratumoral ethanol injection, this study will
attempt to determine the causes of pain associated with 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.
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