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
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center Neurological Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Jeffrey N. Bruce |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01638130 -
Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers
|
N/A |