Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors

Brain Neoplasms, Primary Malignant Clinical Trial

Official title:

A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors

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

• Brain Neoplasms
• Brain Neoplasms, Primary Malignant

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