BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma
• Recurrent Pancreatic Carcinoma
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

BIOLOGICAL

Aldesleukin

Given SC

BIOLOGICAL

Antibody Therapy

Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Oxaliplatin

Given IV

DRUG

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Given IV

BIOLOGICAL

Sargramostim

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Barbara Ann Karmanos Cancer Institute

  lead OTHER

Principal Investigators

• Anthony Shields · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2021-06-21

Completion

2021-06-21

Countries

• United States

Study Locations