Intra-arterial Chemotherapy for Spinal Metastases
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/26/2019 |
| Start Date: | April 2012 |
| End Date: | December 2018 |
Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease
Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most
devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal
and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a
clinical entity known as cord compression that manifests with progressive loss of motor
function and sensation in the legs, as well as bladder and bowel incontinence.
The treatment of spinal metastases is mostly palliative with the goals of improving or
maintaining neurologic function, achieving local tumor control, and spinal stability. Most
patients with spinal metastatic disease are currently treated effectively with radiation
therapy and/or surgery with good results. There are however certain limitations in the
current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted
SMD is in close proximity the spinal cord, delivery of high radiation doses is
contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and
2) there is limit on the cumulative amount of radiation dose, which means that recurrent
tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned,
the main limitation is that some patients are not fit for surgery because of medical
co-morbidities.
This phase I clinical research trial will test the hypothesis that a new minimally invasive
treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients
with SMD.
devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal
and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a
clinical entity known as cord compression that manifests with progressive loss of motor
function and sensation in the legs, as well as bladder and bowel incontinence.
The treatment of spinal metastases is mostly palliative with the goals of improving or
maintaining neurologic function, achieving local tumor control, and spinal stability. Most
patients with spinal metastatic disease are currently treated effectively with radiation
therapy and/or surgery with good results. There are however certain limitations in the
current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted
SMD is in close proximity the spinal cord, delivery of high radiation doses is
contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and
2) there is limit on the cumulative amount of radiation dose, which means that recurrent
tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned,
the main limitation is that some patients are not fit for surgery because of medical
co-morbidities.
This phase I clinical research trial will test the hypothesis that a new minimally invasive
treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients
with SMD.
To date, there is no effective systemic therapy for spinal metastases, and the goal of
treatment is to achieve local control of the tumor. Despite advances in radiation therapy,
there is still a subgroup of patients that cannot be effectively treated with radiation
because of close proximity of the tumor to the spinal cord. In addition, in cases of
recurrent tumors, some patients cannot be re-treated because they reached the maximum allowed
radiation dose. Surgery is the alternative treatment for these patients, but some tumors do
recur after surgery while some patients have comorbidities that make surgery a high-risk
procedure.
Based on our prior experience with selective IA chemotherapy for the treatment of ocular
retinoblastoma and the high local control rates achieved with selective IA injection of
chemotherapy in recurrent limb melanoma (limb infusion and limb perfusion) we expect that
spinal intra-arterial chemotherapy with selective injection of Melphalan in the arteries
feeding the metastatic disease is feasible and safe and may prove beneficial in achieving
local control of the spinal tumor, preventing neurological compromise from cord compression.
This minimally invasive approach can be used in patients in whom radiation therapy and
surgery are contra-indicated and essentially have no other treatment options.
treatment is to achieve local control of the tumor. Despite advances in radiation therapy,
there is still a subgroup of patients that cannot be effectively treated with radiation
because of close proximity of the tumor to the spinal cord. In addition, in cases of
recurrent tumors, some patients cannot be re-treated because they reached the maximum allowed
radiation dose. Surgery is the alternative treatment for these patients, but some tumors do
recur after surgery while some patients have comorbidities that make surgery a high-risk
procedure.
Based on our prior experience with selective IA chemotherapy for the treatment of ocular
retinoblastoma and the high local control rates achieved with selective IA injection of
chemotherapy in recurrent limb melanoma (limb infusion and limb perfusion) we expect that
spinal intra-arterial chemotherapy with selective injection of Melphalan in the arteries
feeding the metastatic disease is feasible and safe and may prove beneficial in achieving
local control of the spinal tumor, preventing neurological compromise from cord compression.
This minimally invasive approach can be used in patients in whom radiation therapy and
surgery are contra-indicated and essentially have no other treatment options.
Inclusion Criteria:
- Patients with metastatic diseases to the spine causing cord compression grades 1, and
2 who are not candidates for the standard treatment of radiation therapy or surgery.
- Patients older than 18 years old.
- Patients able to give informed consent.
Exclusion Criteria:
- MRI findings of grade 3 epidural cord compression.
- Rapidly worsening neurological symptoms.
- The vascular supply to the spinal cord (anterior and/or posterior spinal arteries)
originates from the same segmental arteries (intercostal or lumbar arteries) supplying
the tumor.
- Life expectancy less than 3 months.
- Pregnant or lactating patients.
- Female patients with inadequate contraception.
- History of severe allergy to contrast media.
- Renal insufficiency (Creatinine >1.5mg/dL)
- WBC < 3000 cells/ mm3
- Platelets < 75000 cells/ mm3
We found this trial at
1
site
New York, New York 10710
Principal Investigator: Athos Patsalides, MD
Phone: 212-746-2821
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