Intra-arterial Chemotherapy for Spinal Metastases

NCT01637766 | Completed Phase 1 DMC

• 1 other identifier: 0807009906
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Diseases; Spinal Metastases; Spinal Tumors

Keywords

Spinal Metastases; Spinal Metastatic Disease; Cord Compression; Intra-arterial Chemotherapy; Spinal Tumors

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

Selective intra-arterial chemotherapy

EXPERIMENTAL

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)

Interventions

Melphalan (intra-arterial infusion) DRUG

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.

Also known as: Alkeran

Selective intra-arterial chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College Department of Neurological Surgery

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Spinal Diseases; Spinal Cord Neoplasms; Spinal Cord Compression

Interventions

Melphalan; Infusions, Intra-Arterial

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Athos Patsalides

  Weill Cornell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2012
• First Posted: July 11, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)