Liposomal Irinotecan via Convection-Enhanced Delivery and Magnetic Resonance Imaging with Gadolinium in Treating Patients with Recurrent High Grade Glioma

Inclusion Criteria

• Patients with radiographically proven recurrent, intracranial high grade glioma will be eligible for this protocol; patients must have evidence of tumor progression as determined by RANO criteria following standard therapy * High grade glioma includes glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified) * Magnetic resonance imaging (MRI) must be performed within 21 days prior to enrollment, and patients who are receiving steroids must be on a stable or decreasing dose for at least 5 days prior to imaging; if the steroid dose is increased between the date of imaging and enrollment, a new baseline MRI is required * Patients must have completed only 1 prior course of radiation therapy and must have experienced an interval of greater than 12 weeks from the completion of radiation therapy to study entry
• Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a high grade glioma is made
• There is no limit as to the number or type of prior drug treatments but patients must have radiographic evidence of progressive disease
• Recurrent tumor must be a solid, single, supratentorial, contrast-enhancing HGG which have a tumor diameter no larger than 4 cm or volume of 34 cm^3
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
• Life expectancy > 8 weeks
• Patients with Karnofsky performance status of >= 70
• At the time of treatment on protocol patients must have recovered from the toxic effects of prior therapy: > 10 days from any noncytotoxic investigational agent, > 28 days from prior cytotoxic therapy or Avastin, > 14 days from vincristine, > 42 days from nitrosoureas, > 21 days from procarbazine administration, and > 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the study chair
• Leukocytes > 3,000/mcL
• Absolute neutrophil count > 1,500/mcL
• Platelets > 100,000/mcL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2.5 X institutional upper limit of normal
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• International normalized ratio (INR) < 2.0
• Partial thromboplastin time (PTT) =< institution's upper limit of normal, unless receiving therapeutic low molecular weight heparin
• Women of child-bearing potential and men must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence, etc. prior to study entry, for the duration of study participation, and for 6 months post drug administration; 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
• Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to treatment
• Patients with prior therapy that included interstitial brachytherapy, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either positron emission tomography (PET) or thallium scanning, MR spectroscopy or surgical documentation of disease
• Patients must be able to have MRI brain imaging
• UGT1A1 genotyping prior to treatment

Exclusion Criteria

• Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
• Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
• Contrast-enhancing tumor which crosses the midline
• Multi-focal disease
• Nonparenchymal tumor dissemination (e.g., subependymal or leptomeningeal)
• History of hypersensitivity reactions to products containing irinotecan (irinotecan), topotecan or other topoisomerase inhibitors, gadolinium contrast agents or lipid products
• Ongoing treatment with cytotoxic therapy
• Patients may not be on an enzyme-inducing anti-epileptic drug (EIAED); if previously on an EIAED, patient must be off for at least 10 days prior to CED infusion