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This is a phase I trial using EGFR Bi-armed Activated T-cells (BATs) in combination with standard of care temozolomide (TMZ) and radiation (RT) in patients with glioblastoma (GBM). The purpose of the study is to determine a safe dose of EGFR BATs when given with standard of care therapy.
Full description
In addition to finding the safe dose of EGFR BATs, immune evaluations will be performed as delineated in the schedule of events to measure immune responses during all stages of treatment for GBM.
Enrollment
Sex
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Volunteers
Inclusion criteria
Absolute lymphocyte count ≥ 500/mm3, Absolute neutrophil count (ANC) ≥1,000 /mcL, Platelets ≥ 100,000 / mcL, Hemoglobin ≥ 9 g/dL (or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment), BUN ≤ 1.5 X upper limit of normal (ULN), Serum creatinine within the normal limits OR Measured or calculated creatinine clearance ≥60 mL/min/1.73m2, Serum total bilirubin ≤ 1.5 X ULN OR AST (SGOT) and ALT (SGPT) ≤ 5 X ULN, Albumin >2.5 mg/dL, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN, unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
i. Additional inclusion criteria for sub-cohort: MGMT unmethylated according to UVA pathology testing
Exclusion criteria
Patients with a diagnosis of another malignancy within 3 years of being on-study. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Patients must not be on any treatment for another malignancy.
Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.
Patients with extracranial metastases.
Known hypersensitivity to cetuximab or other EGFR antibody.
Alpha 1,3 Galactose IgE ("alpha gal") test result outside of the reference range (indicating likely hypersensitivity to cetuximab)
Evidence of active bleeding or bleeding diathesis.
Cardiac Status: Patients will be ineligible for treatment on this protocol if (prior to protocol entry):
There is a history of a recent (within one year) myocardial infarction or stroke.
There is a current or prior history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < 45% by MUGA or ECHO).
There is clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA or ECHO results).
Has Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Has received a live vaccine within 30 days of planned start of study therapy.
Has received any treatment for GBM besides surgery.
Females must not be breastfeeding.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
A patient may be excluded if, in the opinion of the treating clinician, the patient is not capable of being compliant.
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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