BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological proof of pancreatic adenocarcinoma; must have locally advanced or metastatic pancreatic cancer who have received at least first line chemotherapy and may have responding, stable or progressive disease
- Expected survival >= 3 months
- Karnofsky performance scale (KPS) >= 70% or Southwestern Oncology Group (SWOG) performance status 0 or 1
- 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)
- Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) < 5.0 times normal
- Left ventricular ejection fraction (LVEF) >= 45% at rest (multigated acquisition scan [MUGA] or echocardiogram [Echo])
- 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
Exclusion Criteria:
- Any chemotherapy related toxicities from prior treatment (> grade 2 per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
- Known hypersensitivity to cetuximab or other EGFR antibody
- Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
- Symptomatic brain metastasis
- Chronic treatment with systemic steroids or another immuno-suppressive agent
- 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
- Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known human immunodeficiency virus (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
- A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy
- Females must not be breastfeeding
- Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant
Sites / Locations
- Wayne State University/Karmanos Cancer Institute
Arms of the Study
Arm 1
Experimental
Treatment (anti-CD3 x anti-EGFR BATs)
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.