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Intra-arterial Chemotherapy for Spinal Metastases (SIAC)

Primary Purpose

Spinal Diseases, Spinal Metastases, Spinal Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melphalan (intra-arterial infusion)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Diseases focused on measuring Spinal Metastases, Spinal Metastatic Disease, Cord Compression, Intra-arterial Chemotherapy, Spinal Tumors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College Department of Neurological Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selective intra-arterial chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in spinal epidural tumor size as depicted on the MRI scans after treatment.

Full Information

First Posted
July 8, 2012
Last Updated
July 31, 2020
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01637766
Brief Title
Intra-arterial Chemotherapy for Spinal Metastases
Acronym
SIAC
Official Title
Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Diseases, Spinal Metastases, Spinal Tumors
Keywords
Spinal Metastases, Spinal Metastatic Disease, Cord Compression, Intra-arterial Chemotherapy, Spinal Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selective intra-arterial chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Melphalan (intra-arterial infusion)
Other Intervention Name(s)
Alkeran
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change in spinal epidural tumor size as depicted on the MRI scans after treatment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athos Patsalides
Organizational Affiliation
Weill Cornell
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College Department of Neurological Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intra-arterial Chemotherapy for Spinal Metastases

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