Convection-Enhanced Delivery of Topotecan in Treating Patients with Recurrent or Progressive WHO Grade III-IV Glioma
- 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
- 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
- Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelet count >= 100,000/uL
- Hemoglobin >= 10 g/dL
- Prothrombin time (PT)/partial prothrombin time (PTT) not above institutional norms
- Estimated glomerular filtration rate (eGFR) of at least 50 mL/min
- Patient is mentally or legally incapacitated at the time of the study
- Known human immunodeficiency virus (HIV) (positive [+]) or has been diagnosed with acquired immunodeficiency syndrome (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
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.
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.
Trial Phase Phase O
Trial Type Treatment
Moffitt Cancer Center
Michael A. Vogelbaum
- Primary ID MCC-19970
- Secondary IDs NCI-2019-02808
- Clinicaltrials.gov ID NCT03927274