Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors
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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 magnetic resonance (MR) imaging techniques.
The study will assess quality of life parameters throughout the follow-up period.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Neoplasms, Primary Malignant |
Procedure: Convection-Enhanced Delivery Drug: Topotecan |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors |
- Time to tumor progression/recurrence [ Time Frame: treatment to progression ] [ Designated as safety issue: Yes ]
- Time to death [ Time Frame: Treatment to time of death ] [ Designated as safety issue: Yes ]
- Grade 3 Adverse Events [ Time Frame: during treatment, post treatment ] [ Designated as safety issue: Yes ]
- Quality of life at follow-up time points [ Time Frame: pre-treatment, during treatment, post treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | December 2015 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Topotecan
Once a plastic catheter is placed, within 24 hours of placement, the catheter will be connected to a small pump at the bedside, and the convection-enhanced delivery of the Topotecan will begin. The Topotecan will be infused for 4 to 5 days after which time the catheters will simply be pulled out. Patients will be monitored with blood tests and MRI scans during the treatment and at different time periods during the following months.
|
Procedure: Convection-Enhanced Delivery
microinfusion pumps to deliver chemotherapy directly into brain tumors
Other Name: Intracerebral Clysis
Drug: Topotecan
chemotherapeutic drug for the treatment of brain tumors
Other Name: Hycamtin
|
Detailed Description:
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 magnetic resonance imaging (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 (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Single primary malignant brain tumor
- Previous treatment with external beam radiation
- Tumor is stereotactically accessible
- Karnofsky Performance Score of at least 60
Exclusion Criteria:
- Diffuse subependymal or Cerebrospinal fluid (CSF) disease
- Tumor involves brainstem, cerebellum or both hemispheres
- Active infection
- Systemic disease associated with unacceptable anesthetic/operative risk
- Previous treatment with topotecan
- Unable to receive MRI scans
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00308165
| United States, New York | |
| Columbia University Medical Center Neurological Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Jeffrey Bruce, MD | Columbia University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey N. Bruce, Edgar M. Housepian Professor of Neurological Surgery Research, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00308165 History of Changes |
| Obsolete Identifiers: | NCT00324844, NCT00452959 |
| Other Study ID Numbers: | AAAA4229 R01CA089395 |
| Study First Received: | March 27, 2006 |
| Last Updated: | January 13, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Recurrent Primary Malignant Brain Tumors Brain Tumors Neoplasms, Brain |
Brain Cancer Brain cancer treatment Topotecan |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 23, 2016