A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

Korábbi kezelés

• Any chemotherapy related toxicities from prior treatment, > grade 2 per CTCAE v4.0
• Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
• A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.

Más betegség

• Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• Known HIV infection
• Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
• Has an active infection requiring systemic therapy

Laborértékek

• Known hypersensitivity to cetuximab or other EGFR antibody

Egyéb

• Symptomatic brain metastasis
• Females must not be breastfeeding
• Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant

• Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS>/= 70% or SWOG performance Status 0 or 1
• Evaluable disease by iRECIST criteria
• Absolute Neutrophil Count (ANC) >/= 1,000/mm\^3
• Lymphocyte count >/= 400/mm\^3
• Platelet Count >/= 75,000/mm\^3
• Hemoglobin >/= 8 g/dL
• Serum Creatinine < 2.0 mg/dl, Creatinine Clearance >/=50 ml/mm (can be calculated or measured)
• Total Bilirubin </= 2 mg/dl (biliary stent is allowed)
• SGPT and SGOT <5.0 times normal
• LVEF >/= 55% at rest (<UGA or Echo)
• Age >/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
• Females of childbearing potential, and males, must be willing to use an effective method of contraception
• Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy