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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00308165
Other study ID # AAAA4229
Secondary ID R01CA089395
Status Active, not recruiting
Phase Phase 1/Phase 2
First received March 27, 2006
Last updated January 13, 2015
Start date March 2004
Est. completion date December 2015

Study information

Verified date January 2015
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00324844
  • NCT00452959

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date December 2015
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Convection-Enhanced Delivery
microinfusion pumps to deliver chemotherapy directly into brain tumors
Drug:
Topotecan
chemotherapeutic drug for the treatment of brain tumors

Locations

Country Name City State
United States Columbia University Medical Center Neurological Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
Jeffrey N. Bruce

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to tumor progression/recurrence treatment to progression Yes
Primary Time to death Treatment to time of death Yes
Primary Grade 3 Adverse Events during treatment, post treatment Yes
Secondary Quality of life at follow-up time points pre-treatment, during treatment, post treatment Yes
See also
  Status Clinical Trial Phase
Recruiting NCT01638130 - Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers N/A