Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy

A vizsgálat adatai

Ki végzi

National Cancer Institute (NCI)

Azonosító

NCT07715903

A regiszteradat frissítve

2026. november 12.

Eredeti leírás

Background:A teljes eredeti leírásKevesebb

Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy

Background:

Cancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump. The HAI pump is installed in the artery that goes to the liver; drugs are administered directly to the liver through this pump. But these tumors often return after treatment. Carfilzomib (CFZ) is a drug approved to treat another kind of cancer. Researchers want to find out if this drug may be helpful when administered through the HAI pump directly to the liver for people with colon, adrenal glands, or bile duct cancer that has spread to the liver.

Objective:

To test the safety of carfilzomib (CFZ) delivered via a hepatic artery infusion (HAI) pump directly to the liver in people with cancer in their liver.

Eligibility:

People aged 18 years or older with cancers of the colon, adrenal glands, or bile ducts that spread to the liver and persist after treatment. They must have a functioning hepatic artery infusion (HAI) pump in place from previous treatment of HAI pump therapy.

Design:

Participants will be screened. They will have a physical exam, blood tests, imaging scans, and a test of their heart function. They will also have a test to show how the blood flows through their liver: A radioactive substance will be injected into a vein, and a special camera will take pictures of the blood flow for up to 1 hour.

Participants will receive the study drug for about 6 months. They will visit the clinic once a week. Their HAI pump will be filled with the drug at each visit; the drug will slowly drain from the pump into the liver. Blood tests and imaging scans will be repeated during the study.

Participants will have follow-up visits 1 and 3 months after their last dose of study drug.

An optional liver biopsy (tissue sample) for research purposes may be done before the study drug is given, and again (optional) within 28 days after first receiving the study drug. Individuals may participate in the study even if they do not agree to have the biopsies done.

...

Kizáró feltételek: Participants with liver metastases amenable to resection; Participants who received floxuridine within 6 weeks prior to the study treatment initiation; Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation; Participants who received any investigational agents within 4 weeks prior to the study treatment initiation; Participants with incontrovertible radiographic evidence of disease progression per the RECIST definition outside of the liver within 3 months prior to the study treatment initiation. Note: Pulmonary lesions less than 1 cm are allowed; Prior radiation to the liver (Yttrium-90 [Y-90] or External Beam Radiation Therapy [EBRT]); History of allergic reactions attributed to compounds of similar chemical composition to CFZ; Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, evaluated by medical history, electrocardiogram (EKG), physical exam, and laboratory testing, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.

INCLUSION CRITERIA:; Participants must have a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC); Participants must have measurable liver-dominant metastatic disease. Note: liver-dominant metastatic disease is defined as >=75% of metastatic disease present in the liver as assessed by the principal investigator; Extrahepatic disease should be treated with anticancer therapy, if applicable, and should be stable by RECIST criteria for at least 6 weeks prior to study treatment initiation; Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place; Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment; Age >= 18 years; Eastern Cooperative Oncology Group (ECOG) performance status <= 2; Participants must have an adequate organ and marrow function as defined below:; Leukocytes > 3,000/mcL; Hemoglobin >= 9 mg/dL; Absolute neutrophil count > 1,500/mcL; Platelets > 100,000/mcL; Total bilirubin < 2 X institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) < 2.5 X institutional (ULN); Alanine aminotransferase (ALT) < 2.5 X institutional (ULN); Creatinine <2 X institutional (ULN); Participants positive for human immunodeficiency virus (HIV) 1/2 antibody must have a negative HIV viral load; Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load; Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load. Note: Participants positive for Hepatitis B surface antigen (HBsAg) are excluded; Women of childbearing potential (WOCBP) must agree to use effective contraception (barrier, hormonal, intrauterine device, abstinence, surgical sterilization) at the study entry and up to 6 months after the last dose of the study drug. A participant may request a male partner to use an effective form of contraception to fulfill this requirement (e.g., condom/barrier); Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 3 months after the last dose of the study drug. A participant may request a female partner to use an effective form of contraception to fulfill this requirement (e.g., intrauterine device, hormonal contraceptives). Men must not freeze or donate sperm within the same period; Women who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding from study treatment initiation through 2 weeks after the last dose of the study drug; Ability of participant to understand and the willingness to sign a written informed consent document.

ClinicalTrials.gov NCT07715903