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Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease

Phase 1
18 Years
80 Years
Open (Enrolling)
Spinal Diseases, Spinal Metastases, Spinal Tumors

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Trial Information

Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication.

Safety Issue:


Principal Investigator

Athos Patsalides, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

Related Keywords:

  • Spinal Diseases
  • Spinal Metastases
  • Spinal Tumors
  • Spinal Metastases
  • Spinal Metastatic Disease
  • Cord Compression
  • Intra-arterial Chemotherapy
  • Spinal Tumors
  • Neoplasm Metastasis
  • Spinal Cord Neoplasms
  • Spinal Neoplasms
  • Spinal Diseases



Weill Cornell Medical College Department of Neurological Surgery New York, New York  10710