Phase I EGFR BATs in Newly Diagnosed Glioblastoma

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.

Inclusion Criteria:

1. Histologically-confirmed newly diagnosed intracranial GBM or gliosarcoma

2. Age ≥ 18 years.

3. Karnofsky Performance Status ≥ 60.

4. Be willing and able to provide written informed consent for the trial.

5. For patients with resection, CT/MRI with contrast must be performed within 72 hours
following resection. Intraoperative post resection MRI is acceptable. No post surgery
CT/MRI is required for patients who have received biopsy.

6. Females of childbearing potential, and males, must be willing to use an effective
method of contraception

7. Females of childbearing potential should have a negative urine or serum pregnancy
test. If the urine test is positive or cannot be confirmed as negative, a serum
pregnancy test will be required.

8. Demonstrate adequate organ function as defined below. All screening labs should be
performed within 10 days prior to apheresis.

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

Exclusion Criteria:

1. 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.

2. Patients with evidence of leptomeningeal dissemination or subependymal spread on
initial MRI.

3. Patients with extracranial metastases.

4. Known hypersensitivity to cetuximab or other EGFR antibody.

5. Alpha 1,3 Galactose IgE ("alpha gal") test result outside of the reference range
(indicating likely hypersensitivity to cetuximab)

6. Evidence of active bleeding or bleeding diathesis.

7. 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).

8. 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).

9. Has received a live vaccine within 30 days of planned start of study therapy.

10. Has received any treatment for GBM besides surgery.

11. Females must not be breastfeeding.

12. 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.

13. A patient may be excluded if, in the opinion of the treating clinician, the patient is
not capable of being compliant.