Trial record 7 of 376 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Diseases"

Intra-arterial Chemotherapy for Spinal Metastases (SIAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01637766
Recruitment Status : Recruiting
First Posted : July 11, 2012
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
Athos Patsalides MD, Weill Medical College of Cornell University

Brief Summary:

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 or disease Intervention/treatment Phase
Spinal Diseases Spinal Metastases Spinal Tumors Drug: Melphalan (intra-arterial infusion) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease
Study Start Date : April 2012
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Selective intra-arterial chemotherapy
Subjects recruited to this study will receive intra-arterial injections of chemotherapy (melphalan) in the branches of the arteries feeding the metastatic spinal tumor. Subjects will receive general anesthesia or conscious sedation. A catheter will be guided using X-ray from the femoral artery at the top of the leg to the arteries of the spine. A dye will be injected through the catheter to show the arteries in greater detail. The chemotherapy is then injected into the tumor. We will inject the maximum systemic dose adjusted to white blood count and platelet count. Subjects will undergo three cycles of chemotherapy three to six weeks apart.
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.

Other Name: Alkeran

Primary Outcome Measures :
  1. Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Change in spinal epidural tumor size as depicted on the MRI scans after treatment. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01637766

Contact: Athos Patsalides, MD 212-764-2821
Contact: Kelly Hannsgen, RN 212-746-2821

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   
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
Principal Investigator: Athos Patsalides, MD MPH Weill Medical College of Cornell University

Responsible Party: Athos Patsalides MD, Assistant Professor of Radiology in Neurological Surgery, Weill Medical College of Cornell University Identifier: NCT01637766     History of Changes
Other Study ID Numbers: 0807009906
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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