Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
Clinical Stage IV Gastric Cancer AJCC v8, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
About this trial
This is an interventional treatment trial for Clinical Stage IV Gastric Cancer AJCC v8
Eligibility Criteria
Inclusion Criteria: PRE-REGISTRATION: Age >= 18 years PRE-REGISTRATION: Disease characteristics Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction (GEJ) Currently receiving first-line therapy with leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) and nivolumab without evidence of disease progression OR planning to start first-line therapy with FOLFOX and nivolumab PRE-REGISTRATION: No radiographic or histological evidence of non-peritoneal metastasis PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 PRE-REGISTRATION: Willingness to provide mandatory blood specimens for correlative research PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research PRE-REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) REGISTRATION: Peritoneal Carcinomatosis Index (PCI) >= 1 and =< 24 obtained =< 30 days prior to registration REGISTRATION: Clinical, pathological, or radiographic evidence of peritoneal metastasis per PCI and Peritoneal Regression Grading Score (PRGS) REGISTRATION: Hemoglobin >= 8.0 g/dL (obtained =< 15 days prior to registration) REGISTRATION: Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 15 days prior to registration) REGISTRATION: Platelet count >= 75,000/mm^3 (obtained =< 15 days prior to registration) REGISTRATION: Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 15 days prior to registration) REGISTRATION: Alanine aminotransferase (ALT) AND aspartate transaminase (AST) =< 1.5 x ULN (obtained =< 15 days prior to registration) REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy, then INR or aPTT is within target range of therapy (obtained =< 15 days prior to registration) REGISTRATION: Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (obtained =< 15 days prior to registration) REGISTRATION: Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only REGISTRATION: Provide written informed consent REGISTRATION: Willingness to provide mandatory blood specimens for correlative research REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) Exclusion Criteria: PRE-REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects: Pregnant persons Nursing persons Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception PRE-REGISTRATION: Any of the following prior therapies: IL-2 or chronic corticosteroids, or immunosuppressive agents NOTE: Inhaled corticosteroids are allowed PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy PRE-REGISTRATION: Uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Or psychiatric illness/social situations that would limit compliance with study requirements Autoimmune disease PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm PRE-REGISTRATION: Active second malignancy currently receiving systemic treatment =< 6 months prior to pre-registration PRE-REGISTRATION: History of myocardial infarction =< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias REGISTRATION: Identification of non-peritoneal metastasis during laparoscopy REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects: Pregnant persons Nursing persons Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception REGISTRATION: Any of the following therapies: prior immune checkpoint inhibitors, prior IL-2, or chronic corticosteroids or immunosuppressive agents NOTE: Inhaled corticosteroids are allowed. One-time antiemetic dose is allowed REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy REGISTRATION: Uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Or psychiatric illness/social situations (e.g., substance abuse) that would limit compliance with study requirements Autoimmune disease requiring systemic treatment Small bowel obstruction REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm REGISTRATION: Active malignancy currently receiving systemic treatment =< 6 months prior to registration REGISTRATION: History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias REGISTRATION: Small bowel obstruction < 15 days prior to registration
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Experimental
Treatment (aldesleukin, nivolumab, chemotherapy)
Patients receive aldesleukin IP on study. Patients also receive standard of care nivolumab IV, leucovorin calcium IV, fluorouracil IV, and oxaliplatin IV on study. Patients also undergo diagnostic laparoscopy with biopsy, PET/CT or PET/MRI, and collection of blood and tissue samples throughout the trial.