Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey N. Bruce, Columbia University
ClinicalTrials.gov Identifier:
NCT00308165
First received: March 27, 2006
Last updated: January 29, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm-Topotecan 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

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308165

Locations
United States, New York
Columbia University Medical Center Neurological Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Jeffrey N. Bruce
Investigators
Principal Investigator: Jeffrey Bruce, MD Columbia University
  More Information

No publications provided

Responsible Party: Jeffrey N. Bruce, Edgar M. Housepian Professor of Neurological Surgery Research, Columbia University
ClinicalTrials.gov Identifier: NCT00308165     History of Changes
Other Study ID Numbers: AAAA4229, R01CA089395
Study First Received: March 27, 2006
Last Updated: January 29, 2014
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:
Neoplasms
Brain 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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014