Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeffrey N. Bruce
• Treatments: Topotecan

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