Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02192359 : Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
PhasePhase 1
AgesMin: 18 Years Max: 69 Years
Eligibility
Inclusion Criteria:

- Patient must be able to understand and be willing to sign a written informed consent
document

- Participant must be willing to comply with study and/or follow-up procedures

- Karnofsky performance status >= 70%

- Life expectancy of >= 3 months

- 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 tumor(s); if a patient is going to be
enrolled to dose level two or higher, the patient must have a component of
supratentorial disease (so as to enable placement of a Rickham reservoir/catheter)
that is amenable to resection or biopsy

- High-grade glioma has recurred or progressed after prior treatment with brain
radiation and temozolomide

- Participant 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

- Based on the neurosurgeon's judgment, there is no anticipated physical connection
between the post-resection tumor cavity and the cerebral ventricles

- Neurosurgeon finds the prospective participant is able to undergo neurosurgery

- Any number of prior therapies is permitted; from the start of study treatment, the
following time periods must have elapsed: 6 weeks from nitrosourea-containing
chemotherapy, 4 weeks from non-nitrosourea-containing chemotherapy (except 23 days
from last daily dose of temozolomide taken in a 5 of 28 day regimen), and 2 weeks
from last dose of a targeted agent (except 4 weeks for bevacizumab); there is no time
period requirement for prior radiation therapy

- Any clinically significant toxicity from prior therapy must have improved to grade 0
or grade 1

- Absolute neutrophil count (ANC) >= 1,500 cells/ul

- Platelets > 100,000 cells/ul

- Total bilirubin =< 2.0 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
4 times institutional upper limit of normal

- Serum creatinine =< 1.5 x the institutional upper limit of normal

- Homozygous negative for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT
1A1)*28 allele

- Absence anti-human leukocyte antigen (HLA) antibodies specific for HLA antigens
expressed by the coagulation factor III (thromboplastin, tissue factor) (F3).cytosine
deaminase (CD).carboxylesterase (CE) NSCs

- Negative serum pregnancy test (women of childbearing potential only)

- Agreement by females of childbearing potential and sexually active males 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

Exclusion Criteria:

- Prior therapy with neural stem cells

- Use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
including hepatic enzyme-inducing anticonvulsants (phenytoin, fosphenytoin,
carbamazepine, phenobarbital, primidone, oxcarbazepine) within 2 weeks prior to start
of study treatment

- Use of moderate to strong CYP3A4 inhibitors within 2 weeks prior to start of study
treatment

- Use of drugs known to inhibit UGT1A1, such as atazanir, gemfibrozil, indinavir, or
ketoconazole, within 2 weeks prior to start of study treatment

- Co-medication that may interfere with study results; e.g. immuno-suppressive agents
other than corticosteroids, such as systemic cyclosporine and tacrilomus; consult
principal investigator for questions, including necessary washout period for the
specific drug

- Flucytosine within 2 weeks prior to start of study treatment

- Use of herbal medications

- Current use (or planned use during the treatment period) of other investigational
agents, or biological, chemotherapy, radiation or other anti-tumor therapy

- Patient has known human immunodeficiency virus (HIV) or hepatitis C infection;
baseline testing for HIV or hepatitis C is not required

- Prospective participant is unable to undergo a magnetic resonance imaging (MRI) with
contrast agent

- Known chronic or active viral infections of the central nervous system (CNS)

- Clinically significant uncontrolled illness

- Active infection requiring antibiotics

- Diagnosis of Gilbert's disease

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to irinotecan

- Known sensitivity to any of the products to be administered during dosing

- Any other active malignancy

- Pregnant women and women who are lactating

- Serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the safety monitoring requirements and completion of
treatment according to this protocol

- Prospective participants who, in the opinion of the investigator, may not be able to
comply with all study procedures (including compliance issues related to
feasibility/logistics)
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02192359      |      Link to official Clinicaltrials.gov listing
Locations
Duarte, California
Facility: City of Hope Medical Center
Investigator: Jana L. Portnow
Contact: Jana L. Portnow Phone: 800-826-4673
Email not avaialable




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