Convection-Enhanced Delivery of Topotecan Hydrochloride in Treating Patients with Recurrent High Grade Glioma

Inclusion Criteria

• Patients must have suspected recurrent malignant glioma (WHO grade III-IV), including recurrent glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma; stereotactic biopsies will be performed to confirm the presence of active tumor by frozen section prior to initiating the treatment
• Patients with tumors of the brain must have been previously treated with surgical resection, temozolomide chemotherapy, and external beam radiation other additional treatments are permitted without limitation * Note: Patients with tumors that are unmethylated are not required to have been treated with temozolomide chemotherapy, as current standard of care (SOC) and clinical trial treatment for patients with unmethylated tumors may exclude temozolomide chemotherapy
• A magnetic resonance (MR) scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect; tumors must be less than approximately 32 cc in total volume, as assessed by the principal investigator (PI) based on pre-enrollment magnetic resonance imaging (MRI); the lesion must be stereotactically accessible
• Patients must have demonstrated evidence of increasing contrast enhancement on MR or computed tomography (CT) imaging while on stable or increasing dose of steroid
• Karnofsky performance score of greater than or equal to 70
• Men and women of childbearing potential must practice birth control; women of child bearing potential must have a urine pregnancy test within 7 days of study entry; in accordance with topotecan hydrochloride (topotecan) administration guidelines, women must practice birth control for at least 1 month following chemotherapy infusion; men must practice birth control for at least four months following termination of chemotherapy infusion
• Patients or appropriate legally authorized representatives must possess the ability to give informed consent
• Patients must be willing to and medically capable of undergoing the surgical operation
• Leukocytes >= 3,000/mcL 14 days or fewer from registration
• Absolute neutrophil count >= 1,500/mcL 14 days or fewer from registration
• Platelets >= 100,000/mcL 14 days or fewer from registration
• Total bilirubin within normal institutional limits 14 days or fewer from registration
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal 14 days or fewer from registration
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal 14 days or fewer from registration
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one month following topotecan infusion; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of topotecan administration; these recommendations regarding men and women of child bearing age are based on the package insert for systemic administration of topotecan

Exclusion Criteria

• Patients with diffuse subependymal or cerebrospinal fluid (CSF) disease
• Patients with tumors involving the cerebellum or both cerebral hemispheres
• Patients with an active infection requiring treatment or having an unexplained febrile illness
• Patients who are known human immunodeficiency virus (HIV), hepatitis B or hepatitis C positive; HIV-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; HIV, hepatitis B and hepatitis C testing is not required for patients not known to have those infections
• Patients with systemic diseases which may be associated with unacceptable anesthetic/operative risk
• Patients who have previously received systemic topotecan for their tumor
• Patients who are not able to receive MRI or positron emission tomography (PET) scans
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan, other topoisomerase inhibitors or gadolinium compounds
• Patients who are currently receiving treatment with agents that are metabolized solely through cytochrome P450 (CYP) 3A4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong CYP2C8 inhibitors; or are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates; caution should be used in patients taking other CYP2C8 - or CYP3A4/5-interacting agents as they may increase the serum concentrations of topotecan; if previously on such agents, the patient must be off of it for at least two weeks prior to study treatment
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing active infection, systemic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limited compliance with study requirements
• Women of child-bearing potential must have a negative pregnancy test 7 or fewer days from registration
• Women must agree not to breast feed while on study