Genetically Modified Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas

This is an interventional treatment trial for Adult Anaplastic Astrocytoma Read More

Inclusion Criteria:

• Patient has a prior, histologically-confirmed, diagnosis of a grade III or IV glioma (including glioblastoma, anaplastic astrocytoma, gliosarcoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma), or has a prior, histologically-confirmed, diagnosis of a grade II glioma and now has radiographic findings consistent with a high-grade glioma (grade III or IV)
• Imaging studies show evidence of recurrent, supratentorial tumor(s)
• Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
• Patient has a Karnofsky performance status of >= 70%
• Patient has a life expectancy of >= 3 months
• Female patients of childbearing potential and sexually-active male patients must agree to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test =< 2 weeks prior to registration
• PROTOCOL-SPECIFIC CRITERIA
• Patient must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy ± chemotherapy
• Patients who will undergo tumor resection must have residual enhancing tumor (i.e. a gross total resection is not anticipated)
• Based on the neurosurgeon's judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles
• Absolute neutrophil count (ANC) of >= 1500 cells/mm^3
• Platelet count >= 100,000 cells/mm^3
• Total bilirubin =< 2.0 mg/dl
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 4 times the institutional upper limit of normal
• Serum creatinine =< the institutional upper limit of normal
• There is no limit to the number of prior therapies
• Patient must be able to understand and be willing to sign a written informed consent document
• INCLUSION CRITERIA FOR MTD COHORT 2
• Patient has a prior, histopathologically-confirmed diagnosis of glioblastoma
• Patient has not received any therapy for recurrent disease
• INCLUSION CRITERIA FOR PROCEEDING TO TREATMENT WITH IRINOTECAN DURING CYCLE 1
• A patient's daily total dose of dexamethasone must be =< 16 mg by day 3

Exclusion Criteria:

• Patient is homozygous or heterozygous for the UDP glycosyltransferase 1 family, polypeptide A1*28 allele (UGT 1A1*28) allele and/or has Gilbert's disease
• Patient must not be taking any cytochrome P450 3A4 (CYP3A4) hepatic enzyme-inducing anticonvulsants (phenytoin, fosphenytoin [Cerebyx], carbamazepine, phenobarbital, primidone, oxcarbazepine) or other moderate to strong CYP3A4 inhibitors or inducers for at least 2 weeks prior to start of study treatment
• Patient has anti-human leukocyte antigen (HLA) antibodies specific for HLA antigens expressed by the F3.CD.CE NSCs
• Patient has not recovered from any toxicity of prior therapies; an interval of at least 6 weeks must have elapsed since taking a nitrosourea-containing chemotherapy regimen, at least 4 weeks since completing a non-nitrosourea-containing cytotoxic chemotherapy regimen, and at least 2 weeks from taking the last dose of a targeted agent and the start of study treatment, with the exception of bevacizumab, where a wash out period of at least 4 weeks is required before starting study treatment
• Patient is taking flucytosine
• Patient is unable to undergo a magnetic resonance imaging (MRI)
• Patient has chronic or active viral infections of the central nervous system (CNS) or an uncontrolled illness
• Patient may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is participating in this study
• A patient with another active malignancy is ineligible for this study
• Non-compliance