Intra-arterial Chemotherapy for Spinal Metastases (SIAC)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Spinal Diseases
Spinal Metastases
Spinal Tumors
Drug: Melphalan (intra-arterial infusion)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in spinal epidural tumor size as depicted on the MRI scans after treatment. [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selective intra-arterial chemotherapy 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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637766

Contacts
Contact: Athos Patsalides, MD 212-764-2821 atp9002@med.cornell.edu
Contact: Kimberly Salvaggio, RN 212-746-4998

Locations
United States, New York
Weill Cornell Medical College Department of Neurological Surgery Recruiting
New York, New York, United States, 10065
Contact: Athos Patsalides, MD    212-746-2821    atp9002@med.cornell.edu   
Principal Investigator: Athos Patsalides, MD         
Sub-Investigator: Pierre Gobin, MD         
Sub-Investigator: Mark Bilsky, MD         
Sub-Investigator: Kimberly Salvaggio, NP         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Athos Patsalides, MD MPH Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Athos Patsalides MD, Assistant Professor of Radiology in Neurological Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01637766     History of Changes
Other Study ID Numbers: 0807009906
Study First Received: July 8, 2012
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Spinal Metastases
Spinal Metastatic Disease
Cord Compression
Intra-arterial Chemotherapy
Spinal Tumors

Additional relevant MeSH terms:
Neoplasm Metastasis
Spinal Cord Neoplasms
Spinal Diseases
Spinal Neoplasms
Bone Diseases
Bone Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Spinal Cord Diseases
Melphalan
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014