BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
NCT ID: NCT02620865
Last Updated: 2023-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2015-12-31
2021-06-21
Brief Summary
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Detailed Description
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I. Confirm in a single dose phase I (3 to 6 patients \[pts\]) that 8 infusions of 10\^10 epidermal growth factor receptor (EGFR) bispecific antibody armed activated T cells (BATs) given twice per week in combination with interleukin (IL)-2 (aldesleukin) (300,000 IU/m\^2/day) and granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) (250 ug/m\^2/twice weekly) beginning 3 days before the 1st infusion and ending on the day of the last infusion is safe.
II. Perform a phase II clinical trial to estimate the clinical efficacy of 8 infusions of 10\^10 EGFR BATs in combination with IL-2 and GM-CSF in 39 evaluable pts (including the 3-6 pts in the single dose phase I).
SECONDARY OBJECTIVES:
I. Determine if infusions of EGFR BATs significantly increase cellular or humoral anti-pancreatic cancer (PC) responses by peripheral blood mononuclear cells (PBMC) at different time points after last EGFR BATs infusion and if those responses persist beyond 2 months (mos).
II. Obtain original tumor paraffin blocks prior to treatment and evaluate blocks for cluster of differentiation (CD)3, CD4, CD8, programmed cell death (PD)1/programmed cell death ligand (PDL)1, monocytes subpopulations, myeloid-derived suppressor cells (MDSC), and cytoplasmic interferon (IFN)-gamma and IL-10 by immunohistochemical staining to quantitate type and number of tumor infiltrating lymphocytes (TILs) in the tumor microenvironment to estimate whether the type and number correlate with clinical responses.
III. To determine the time to progression (TTP).
OUTLINE: This is a phase Ib, dose-escalation study of anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells followed by a phase II study.
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride intravenously (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 subcutaneously (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.
After completion of study treatment, patients are followed up for 18 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Aldesleukin
Given SC
Antibody Therapy
Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil
Given IV
Gemcitabine Hydrochloride
Given IV
Irinotecan Hydrochloride
Given IV
Laboratory Biomarker Analysis
Correlative studies
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Sargramostim
Given SC
Interventions
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Aldesleukin
Given SC
Antibody Therapy
Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil
Given IV
Gemcitabine Hydrochloride
Given IV
Irinotecan Hydrochloride
Given IV
Laboratory Biomarker Analysis
Correlative studies
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Sargramostim
Given SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Anthony F. Shields, MD PhD
Principal Investigator
Principal Investigators
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Anthony Shields
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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References
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Lum LG, Thakur A, Choi M, Deol A, Kondadasula V, Schalk D, Fields K, Dufrense M, Philip P, Dyson G, Aon HD, Shields AF. Clinical and immune responses to anti-CD3 x anti-EGFR bispecific antibody armed activated T cells (EGFR BATs) in pancreatic cancer patients. Oncoimmunology. 2020 Jun 10;9(1):1773201. doi: 10.1080/2162402X.2020.1773201.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2015-01942
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-100
Identifier Type: OTHER
Identifier Source: secondary_id
2015-100
Identifier Type: -
Identifier Source: org_study_id
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