Clinical Trial 19970

Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT03927274

Phase: N/A
Principal Investigator: Vogelbaum, Michael

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Overview

Study Title

A Pilot Trial of Intratumorally-Administered Topotecan using Convection-Enhanced Delivery (CED) in Patients with Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy (IND 117,240)

Summary

Objective

- To investigate by MR imaging the spatial and temporal distribution of topotecan in enhancing or nonenhancing 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. - 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 with recurrent/progressive HGG

Treatments

Therapies

Chemotherapy (NOS); Surgery

Medications

Topotecan ()

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;

Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent

Laboratory values within the following ranges: Absolute neutrophil count (ANC) ≥ 1,500 / μL, Platelet count ≥ 100,000 / μL, Hemoglobin ≥ 10 g / dL, PT/PTT not above institutional norms, Estimated glomerular filtration rate (eGFR) of at least 50 mL/min

Exclusion Criteria

Patient 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 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)

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