PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic Cancer
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, hu5B1-TCO, 64Cu-Tz-SarAr, 20-409, Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for enrollment if they fulfill the following criteria: Signed informed consent 18 years of age or older Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC). Patients who are surgical candidates for tumor resection or for biopsy or patients with metastatic disease, who are to undergo biopsy prior to standard of care treatment. Patients who have received neoadjuvant chemotherapy or radiation therapy who are scheduled to undergo surgery are eligible At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects Patient with increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy ECOG performance status of 0 to 2 Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109 /L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count >75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal vi. Creatinine clearance (CLcr) (> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) Willingness to participate in collection of pharmacokinetic samples Exclusion Criteria: Patients will be excluded from the study if they fulfill any of the following criteria: Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy Major surgery other than diagnostic surgery within 4 weeks of Study Day 1 History of anaphylactic reaction to human, or humanized, antibody Other on-going cancer therapy with investigational agents Known history of HIV Pregnant or currently breast-feeding a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment. Psychiatric illness/social situations that would interfere with compliance with study requirements.
Sites / Locations
- Memorial Sloan Kettering Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Participants with Pancreatic Cancer
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma