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| Sponsored by: |
Columbia University |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00308165 |
Purpose
This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body.
This study will also evaluate advanced MR imaging techniques. The study will assess quality of life parameters throughout the follow-up period.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Neoplasms, Primary Malignant |
Drug: Topotecan Procedure: Convection-Enhanced Delivery (Intracerebral Clysis) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors |
| Estimated Enrollment: | 35 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | March 2008 |
Clinical efficacy with chemotherapy has been discouraging for malignant brain tumors, mostly because of side effects and delivery limitations. Because they are locally invasive and rarely metastasize, malignant gliomas have features that make them uniquely amenable to new strategies of regional drug delivery. Intracerebral clysis (convection-enhanced delivery) is a novel drug delivery strategy that uses a microinfusion pump to establish a pressure gradient in the brain via implanted catheters. The pressure gradient produces convective forces that distribute a therapeutic agent throughout the tumor and surrounding brain tissue.
Non-invasive MRI methods of monitoring drug distribution and treatment response have been developed to maximize the clinical applications and minimize complications associated with treatment risks.
Study participants will be taken to the operating room to have 2 catheters surgically placed into their tumor and surrounding tumor bed. These catheters will then be connected to small infusion pumps which will slowly infuse topotecan continuously over 4-5 days. Patients will have daily MRI scans while in the hospital. Upon completion of the experimental treatment, patients will be discharged and will be followed up in the outpatient clinic.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Liza Kelly, N.P. | (212) 305-1282 | lk127@columbia.edu |
| United States, New York | |
| Columbia University Medical Center Neurological Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Jeffrey Bruce, MD | |
| Principal Investigator: | Jeffrey Bruce, MD | Columbia University Medical Center |
More Information
| Study ID Numbers: | AAAA-4229, RO1 CA089395 |
| Study First Received: | March 27, 2006 |
| Last Updated: | February 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00308165 |
| Health Authority: | United States: Food and Drug Administration |
|
Recurrent Primary Malignant Brain Tumors Brain Tumors Neoplasms, Brain |
Brain Cancer Brain cancer treatment Topotecan |
|
Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Topotecan |
Brain Diseases Nervous System Neoplasms Recurrence |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |
