This early phase I trial studies how well convection-enhanced delivery of topotecan works in treating patients with World Health Organization (WHO) grade III-IV glioma that that has come back (recurrent) or is growing, spreading, or getting worse (progressive). Convection-enhanced delivery is a type of procedure that facilitates targeted delivery of pharmaceuticals to the brain. It involves a minimally invasive surgical exposure of the brain, followed by placement of catheters directly into the brain tumor, reaching high concentrations within brain tumor tissue. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving convection-enhanced delivered topotecan may work better than traditional ways in treating patients with WHO grade III-IV glioma.
Additional locations may be listed on ClinicalTrials.gov for NCT03927274.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution of topotecan hydrochloride (topotecan) in enhancing or non-enhancing bulk tumor administered by convection-enhanced delivery (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.
II. To investigate by MR imaging the influence of the rate and topotecan concentration, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG.
SECONDARY OBJECTIVES:
I. To investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan.
II. To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and infusion rates.
III. To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.
OUTLINE: Patients are assigned to 1 of 3 arms.
ARM I: Patients with predominantly enhancing mass volume of 8 cc or less undergo stereotactic implantation of a Cleveland Multiport Catheter placed into the brain tumor and then undergo an MRI or computed tomography (CT) scan. Patients then receive topotecan hydrochloride and gadopentetate dimeglumine via CED over 4 hours.
ARM II-III: Patients with predominantly enhancing mass volume of > 8 cc or non-enhancing mass undergo stereotactic implantation of 2 Cleveland Multiport Catheters placed into the brain tumor and then undergo an MRI or CT scan. Patients then receive topotecan hydrochloride and gadopentetate dimeglumine via CED over 48 hours.
After completion study, patients are followed up between 15-21 days, then every 2 months for 12 months.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorMichael A. Vogelbaum
