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

Withdrawn before enrolling · Phase 1

Conditions studied: Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

In brief

This phase I trial studies the side effects and best dose of genetically modified stem cells when given together with irinotecan hydrochloride in treating patients with recurrent high-grade gliomas. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Placing a gene that has been created in the laboratory into neural stem cells and injecting it into the brain may help irinotecan hydrochloride kill more tumor cells once it reaches the brain.

Key facts

Study ID

NCT02055196

Run by

City of Hope Medical Center

People needed

0

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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