RECRUITING

Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis

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Conditions

Clinical Stage IV Gastric Cancer AJCC v8Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaMetastatic Gastric CarcinomaMetastatic Malignant Neoplasm in the Peritoneum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase Ib trial test effects of aldesleukin in combination with nivolumab and standard chemotherapy in treating patients with gastric cancer that has spread to the tissue lining of the abdomen (peritoneal metastasis). Aldesleukin is similar to a protein that naturally exists in the body that stimulates the immune system to fight infections. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving aldesleukin in combination with nivolumab and standard chemotherapy may work better in treating patients with gastric cancer with peritoneal metastasis.

Official Title

COordinated Nivolumab and IntraperiToneal IL-2 for Gastric CanceR With PeritOneaL Metastasis (CONTROL) Phase 1b Pilot Study

Quick Facts

Study Start:2023-11-29
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05802056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRE-REGISTRATION: Age \>= 18 years
  2. * PRE-REGISTRATION: Disease characteristics
  3. * Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
  4. * 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
  5. * PRE-REGISTRATION: No radiographic or histological evidence of non-peritoneal metastasis
  6. * PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  7. * PRE-REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
  8. * PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
  9. * PRE-REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  10. * REGISTRATION: Peritoneal Carcinomatosis Index (PCI) \>= 1 and =\< 24 obtained =\< 30 days prior to registration
  11. * REGISTRATION: Clinical, pathological, or radiographic evidence of peritoneal metastasis per PCI and Peritoneal Regression Grading Score (PRGS)
  12. * REGISTRATION: Hemoglobin \>= 8.0 g/dL (obtained =\< 30 days prior to registration)
  13. * REGISTRATION: Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 30 days prior to registration)
  14. * REGISTRATION: Platelet count \>= 75,000/mm\^3 (obtained =\< 30 days prior to registration)
  15. * REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 30 days prior to registration)
  16. * REGISTRATION: Alanine aminotransferase (ALT) AND aspartate transaminase (AST) =\< 1.5 x ULN (obtained =\< 30 days prior to registration)
  17. * 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 =\< 30 days prior to registration)
  18. * REGISTRATION: Calculated creatinine clearance \>= 40 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to registration)
  19. * REGISTRATION: Negative pregnancy test done =\< 8 days prior to registration, for persons of childbearing potential only
  20. * REGISTRATION: Provide written informed consent
  21. * REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
  22. * REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
  23. * REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  1. * PRE-REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
  2. * Pregnant persons
  3. * Nursing persons
  4. * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
  5. * PRE-REGISTRATION: Any of the following prior therapies: IL-2 or chronic corticosteroids, or immunosuppressive agents
  6. * NOTE: Inhaled corticosteroids are allowed
  7. * 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
  8. * PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  9. * PRE-REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
  10. * Ongoing or active infection
  11. * Symptomatic congestive heart failure
  12. * Unstable angina pectoris
  13. * Cardiac arrhythmia
  14. * Or psychiatric illness/social situations that would limit compliance with study requirements
  15. * Autoimmune disease
  16. * PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  17. * PRE-REGISTRATION: Active second malignancy currently receiving systemic treatment =\< 6 months prior to pre-registration
  18. * 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
  19. * REGISTRATION: Identification of non-peritoneal metastasis during laparoscopy
  20. * REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
  21. * Pregnant persons
  22. * Nursing persons
  23. * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
  24. * REGISTRATION: Any of the following therapies: prior immune checkpoint inhibitors, prior IL-2, or chronic corticosteroids or immunosuppressive agents
  25. * NOTE: Inhaled corticosteroids are allowed. One-time antiemetic dose is allowed
  26. * 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
  27. * REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
  28. * REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
  29. * Ongoing or active infection
  30. * Symptomatic congestive heart failure
  31. * Unstable angina pectoris
  32. * Cardiac arrhythmia
  33. * Or psychiatric illness/social situations (e.g., substance abuse) that would limit compliance with study requirements
  34. * Autoimmune disease requiring systemic treatment
  35. * Small bowel obstruction
  36. * REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  37. * 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
  38. * REGISTRATION: Small bowel obstruction \< 15 days prior to registration

Contacts and Locations

Principal Investigator

Travis E. Grotz, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Travis E. Grotz, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Clinical Stage IV Gastric Cancer AJCC v8
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Metastatic Gastric Carcinoma
  • Metastatic Malignant Neoplasm in the Peritoneum