A Phase I Study of Anti-CD3 x Cetuximab-Armed Activated T Cells, Low Dose IL-2, and GM-CSF for EGFR-Positive, Advanced Solid Tumors

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed solid tumor type (ex. Head and Neck
Squamous Cell Carcinoma, Colorectal, Pancreatic, Gastric, Esophageal, Renal,
Prostate, Breast and Ovarian cancers, etc.); high risk, recurrent, refractory, or
metastatic disease after ≥ 1 prior first-line regimen (chemotherapy or radiotherapy)

- Documented EGFR-positive disease (any expression level) by immunohistochemistry (IHC)

- No clinical evidence of active brain metastases; patients with brain metastases are
eligible provided they have received definitive radiotherapy or chemotherapy and/or
have undergone surgical resection for brain metastases

- No prior hematological malignancy

- Karnofsky performance status (PS) 60-100% OR RCOG PS 0-2

- Life expectancy ≥ 3 months

- Not pregnant or nursing

- Fertile patients must use contraception

- Granulocytes ≥ 1,000/mm3

- Platelet count ≥ 50,000/mm3

- Hemoglobin ≥ 8g/dL

- BUN ≤ 2.0 times normal

- Serum creatinine ≤ 2.0mg/dL

- Bilirubin ≤ 1.5 times normal (with or without liver metastases)

- Hepatitis B surface antigen and HIV negative

- LVEF ≥ 45% at rest by MUGA

- No evidence of depressed left ventricular function

- No other malignancy, except for the following:

- History of curatively treated in situ squamous cell carcinoma or basal cell carinoma
of the skin

- History of other curatively treated malignancy (except those with a hematologic
origin) for with the patient has remained in complete remission > 5 years after
completing therapy (as documented by history, physical exams, tumor markers, and
radiology scanning)

Exclusion Criteria

- Serious medical or psychiatric illness that would preclude giving informed consent or
receiving intensive treatment

- Recent myocardial infarction (within the past year)

- Current angina/coronary symptoms requiring medications

- Clinical evidence of congestive heart failure requiring medical management
(irrespective of MUGA results)

- Systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 m Hg; patients with
elevated BP must have it controlled by anti-hypertensive medications for at least 7
days prior to the infusion

- Clinical evidence of active brain metastases

Prior/Concurrent Therapy

- More than 4 weeks since prior chemotherapy or radiotherapy

- At least 4 weeks since prior cetuximab or small molecule EGFR-inhibitors including,
but not limited to, gefitinib or erlotinib hydrochloride

- No concurrent radiotherapy

- No concurrent steroids except for treatment or adrenal failure, septic shock, or
pulmonary toxicity or hormones for non-disease-related conditions(e.g., insulin for
diabetes)