Intra-arterial Chemotherapy for Spinal Metastases (SIAC)

This study is currently recruiting participants.
Verified July 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Athos Patsalides MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01637766
First received: July 8, 2012
Last updated: July 10, 2012
Last verified: July 2012

July 8, 2012
July 10, 2012
April 2012
April 2015   (final data collection date for primary outcome measure)
Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication. [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01637766 on ClinicalTrials.gov Archive Site
Change in spinal epidural tumor size as depicted on the MRI scans after treatment. [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intra-arterial Chemotherapy for Spinal Metastases
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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spinal Diseases
  • Spinal Metastases
  • Spinal Tumors
Drug: Melphalan (intra-arterial infusion)

Patients will undergo a minimally invasive procedure called spinal angiography. This procedure will identify the arteries feeding the tumor causing cord compression and will determine whether chemotherapy can be safely infused.

The chemotherapy will be infused via a tiny soft plastic tube (called "microcatheter") at the tumor site over approximately 30 minutes.

The drug of choice is Melphalan (trade name Alkeran) at a maximum dose of 16mg/m2, adjusted for white cell count, platelet count and renal function.

We will perform up to three intra-arterial chemotherapy treatments in 3-6 week intervals, based on the results of complete blood counts.

Experimental: Selective intra-arterial chemotherapy
Intervention: Drug: Melphalan (intra-arterial infusion)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Athos Patsalides, MD 212-764-2821 atp9002@med.cornell.edu
Contact: Kimberly Salvaggio, RN 212-746-4998
United States
 
NCT01637766
0807009906
No
Athos Patsalides MD, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Athos Patsalides, MD MPH Weill Medical College of Cornell University
Weill Medical College of Cornell University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP