Overview

This trial is active, not recruiting.

Condition brain neoplasms, primary malignant
Treatments convection-enhanced delivery, topotecan
Phase phase 1/phase 2
Sponsor Jeffrey N. Bruce
Start date March 2004
End date September 2011
Trial size 18 participants
Trial identifier NCT00308165, AAAA4229, R01CA089395

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
convection-enhanced delivery Intracerebral Clysis
microinfusion pumps to deliver chemotherapy directly into brain tumors
topotecan Hycamtin
chemotherapeutic drug for the treatment of brain tumors

Primary Outcomes

Measure
Time to tumor progression/recurrence
time frame: treatment to progression
Time to death
time frame: Treatment to time of death
Grade 3 Adverse Events
time frame: during treatment, post treatment

Secondary Outcomes

Measure
Quality of life at follow-up time points
time frame: pre-treatment, during treatment, post treatment

Eligibility Criteria

Male or female participants at least 1 year old.

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

Additional Information

Official title A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors
Principal investigator Jeffrey Bruce, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Columbia University.