Glioma of Brain
Conditions
Keywords
Glioma, Brain Tumor, High Grade Glioma
Brief summary
The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.
Interventions
DRUGTopotecan
Intratumorally-administered topotecan using convection-enhanced delivery (CED) in patients with suspected recurrent/progressive High Grade Glioma (HGG) requiring stereotactic biopsy and is focused on investigating topotecan brain tissue distribution and determining the safety, toxicity, and tolerability of intratumorally-administered topotecan.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression. * 18 years of age or older * Karnofsky Performance Status 70-100; * MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect; * Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent * Adequate organ function as indicated in protocol
Exclusion criteria
* Participant is mentally or legally incapacitated at the time of the study; * Known HIV(+) or has been diagnosed with AIDS * Participation in another investigational drug study in the prior 4 weeks * Positive pregnancy test in a female * Patient, in the opinion of the investigator, is likely to be poorly compliant. * Diffuse subependymal or Cerebral Spinal Fluid (CSF) disease * Tumors involving the cerebellum * Tumor enhancement involving both hemispheres * Active infection requiring treatment * Unexplained febrile illness * Radiation or chemotherapy within 4 weeks of enrollment * Systemic diseases associated with unacceptable anesthesia or operative risk * Inability to undergo magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of topotecan in tumor tissue | Treatment day 1 | The spatial distribution of intratumorally-administered topotecan will be determined using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) experienced by participants | Up to 48 weeks | — |
| Extent of topotecan backflow | Treatment day 1 | Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan |
Countries
United States
Outcome results
None listed