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Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors

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ClinicalTrials.gov Identifier: NCT00308165
Recruitment Status : Unknown
Verified January 2015 by Jeffrey N. Bruce, Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : March 29, 2006
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Jeffrey N. Bruce, Columbia University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Brain Neoplasms, Primary Malignant Procedure: Convection-Enhanced Delivery Drug: Topotecan Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : September 2011
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to tumor progression/recurrence [ Time Frame: treatment to progression ]
  2. Time to death [ Time Frame: Treatment to time of death ]
  3. Grade 3 Adverse Events [ Time Frame: during treatment, post treatment ]

Secondary Outcome Measures :
  1. Quality of life at follow-up time points [ Time Frame: pre-treatment, during treatment, post treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308165


Locations
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United States, New York
Columbia University Medical Center Neurological Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Jeffrey N. Bruce
Investigators
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Principal Investigator: Jeffrey Bruce, MD Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeffrey N. Bruce, Edgar M. Housepian Professor of Neurological Surgery Research, Columbia University
ClinicalTrials.gov Identifier: NCT00308165    
Obsolete Identifiers: NCT00324844, NCT00452959
Other Study ID Numbers: AAAA4229
R01CA089395 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Jeffrey N. Bruce, Columbia University:
Recurrent Primary Malignant Brain Tumors
Brain Tumors
Neoplasms, Brain
 Brain Cancer
Brain cancer treatment
Topotecan
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents