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Not yet recruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Infusions, Blood draws, Physical exams, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These liver tumors are often treated using a hepatic artery infusion (HAI) pump."
  • "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."
  • "They will have a physical exam, blood tests, imaging scans, and a test of their heart function."
  • "Participants will receive the study drug for about 6 months."
  • "Blood tests and imaging scans will be repeated during the study."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of carfilzomib given directly to the liver through a hepatic artery infusion (HAI) pump. It is for adults with colon or rectal, adrenal gland, or bile duct cancer that has spread mainly to the liver and remains after treatment. Participants must already have a working HAI pump.

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. ...

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with one of the listed cancers confirmed by a tissue or cell test.
  • Have tumors that can be measured, with at least 75% of the cancer spread in the liver. Cancer outside the liver must be treated if needed and stable for at least 6 weeks.
  • Have had HAI pump treatment and still have a working pump. Cancer must have grown or remained after HAI floxuridine and usual treatment, or those treatments could not be tolerated.
  • Be able to care for yourself and be out of bed or a chair for at least half the day. Blood counts and liver and kidney tests must meet study limits.
  • If certain HIV or hepatitis B or C antibody tests are positive, blood tests must show no detectable virus. A positive hepatitis B surface antigen test rules out joining.
  • Follow birth control rules through 6 months after the last dose for women who can become pregnant, and 3 months for men. Men must not freeze or donate sperm during that time.
  • Stop or delay breastfeeding from the start of treatment until 2 weeks after the last dose.
  • Be able to understand the study and sign a consent form.

Who can't join

  • Liver tumors that can be removed with surgery.
  • Floxuridine within 6 weeks, any cancer treatment within 2 weeks, or an experimental drug within 4 weeks before study treatment starts.
  • Scans clearly show cancer growing outside the liver within the past 3 months. Lung spots smaller than 1 centimeter are allowed.
  • Past radiation treatment to the liver.
  • Past allergic reactions to drugs with a chemical makeup like carfilzomib.
  • A positive pregnancy test at screening.
  • An uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat.
  • A social situation that makes participation too risky, prevents the study team from judging results, or limits the ability to follow study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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. EXCLUSION CRITERIA: * 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.

Study sites (1)

MD