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NCT01637766 · ClinicalTrials.gov registry record · Phase 1
Intra-arterial Chemotherapy for Spinal Metastases
A Phase 1 study of Spinal Metastases and Spinal Diseases, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01637766 is a Phase 1 study of Spinal Metastases and Spinal Diseases that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 12 participants, below the 115-participant average among 5 other Spinal Metastases trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01637766, a Phase 1 study of Spinal Metastases and Spinal Diseases, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Melphalan (intra-arterial infusion)
Study Locations (1)
New York
- Weill Cornell Medical College Department of Neurological Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01637766
The ClinicalTrials.gov registry entry for NCT01637766 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 5 other Spinal Metastases trials with a reported enrollment target (90% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Spinal Metastases appearing as the primary indexed condition, and to 1 intervention - of which Melphalan (intra-arterial infusion) is the first listed.
NCT01637766 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01637766 about?
NCT01637766 is a clinical study titled "Intra-arterial Chemotherapy for Spinal Metastases". 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 c...
What is the current status of trial NCT01637766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-04. Estimated completion is 2018-12.
What conditions does trial NCT01637766 study?
This clinical trial studies the following conditions: Spinal Metastases, Spinal Diseases, Spinal Tumors.
What interventions are being tested in trial NCT01637766?
The interventions under investigation include: Melphalan (intra-arterial infusion) (DRUG).
Who is sponsoring clinical trial NCT01637766?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01637766 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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