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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT02620865
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aldesleukin — BIOLOGICAL
    Given SC
  • Antibody Therapy — BIOLOGICAL
    Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
  • Fluorouracil — DRUG
    Given IV
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Paclitaxel Albumin-Stabilized Nanoparticle Formulation — DRUG
    Given IV
  • Sargramostim — BIOLOGICAL
    Given SC

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Apr 2023
Primary completion
Jun 21, 2021
Completion
Jun 21, 2021

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Median Overall Survival (OS) [ Time Frame: Up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-

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Wayne State University/Karmanos Cancer Institute· Detroit, MI

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