Bispecific Antibody Armed Activated T-cells With Aldesleukin and Sargramostim in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed activated T-cells when given together with aldesleukin and sargramostim and to see how well they work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Bispecific antibody armed activated T-cells are the patient's own T cells that are coated with a bispecific antibody comprising 2 antibodies chemically joined together. These antibodies have specific targets and binding properties that may give the T cells a greater ability to seek out, attach to, and kill more cancer cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Aldesleukin; Antibodies; Antibodies, Bispecific; Calcium; Calcium, Dietary; Camptothecin; Fluorouracil; Folic Acid; Gemcitabine; Immunoglobulins; Interleukin-2; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin; Paclitaxel; Sargramostim

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