Spinal DiseasesPhase 1SIACNCT01637766
Intra-arterial Chemotherapy for Spinal Metastases
A Phase 1 study testing Melphalan (intra-arterial infusion) in people with Spinal Diseases and Spinal Metastases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Diseases, Spinal Metastases, Spinal Tumors
- What is being tested?
- Melphalan (intra-arterial infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- History of severe allergy to contrast media.
- Renal insufficiency (Creatinine >1.5mg/dL)
- WBC < 3000 cells/ mm3
- Platelets < 75000 cells/ mm3
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College Department of Neurological Surgery
New York, New York, 10065
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Diseases, Spinal Metastases, Spinal Tumors
- Being tested
- Melphalan (intra-arterial infusion)
- Keywords
- Spinal Metastases, Spinal Metastatic Disease, Cord Compression, Intra-arterial Chemotherapy, Spinal Tumors
- Medical subject headings
- Spinal Diseases, Spinal Cord Neoplasms, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melphalan (intra-arterial infusion)Drug
Also called Alkeran
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Melphalan (intra-arterial infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication.
Measured: 30 days
Secondary outcomes (1)
Change in spinal epidural tumor size as depicted on the MRI scans after treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athos Patsalides, Principal investigator, Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637766
- Sponsor's protocol ID
- 0807009906
- Acronym
- SIAC
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2012
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease
- ClinicalTrials.gov ID
- NCT01637766
- Acronym / sponsor ID
- SIAC / 0807009906
- Conditions
- Spinal Diseases, Spinal Metastases, Spinal Tumors
- Keywords
- Spinal Metastases, Spinal Metastatic Disease, Cord Compression, Intra-arterial Chemotherapy, Spinal Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective intra-arterial chemotherapy | Experimental | Drug: Melphalan (intra-arterial infusion)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melphalan (intra-arterial infusion)Also: AlkeranPatients 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. | Drug | Selective intra-arterial chemotherapy |
Primary outcome
Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication.
Time frame: 30 days
1 secondary outcome
Change in spinal epidural tumor size as depicted on the MRI scans after treatment.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athos Patsalides principal investigator
Weill Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melphalan (intra-arterial infusion) in people with Spinal Diseases and Spinal Metastases, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients in whom intra-arterial chemotherapy is performed without severe complication. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.