Carfilzomib for Liver Cancer

KM
JM
Overseen ByJonathan M Hernandez, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a drug called Carfilzomib, a type of chemotherapy, to determine its effectiveness in treating liver cancer that has spread from the colon, adrenal glands, or bile ducts. The trial focuses on the safety of delivering this drug directly to the liver using a special pump. Individuals with a hepatic artery infusion pump installed, whose cancer persists after treatment, may be suitable candidates. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received any anticancer therapy within 2 weeks before starting the study treatment.

Is there any evidence suggesting that carfilzomib is likely to be safe for humans?

Research has shown that carfilzomib is generally well-tolerated in cancer treatments. Earlier studies reported that most side effects were mild to moderate, such as slight increases in liver enzymes, a common occurrence with many medications. These side effects are usually not serious and can often be managed with regular check-ups.

Carfilzomib is already approved for treating another type of cancer, indicating thorough study. It is not processed by the liver, which might reduce the risk of liver-related side effects. However, a warning exists about possible liver issues, so doctors will closely monitor liver function during treatment.

Some studies have observed serious side effects, but these are less common. Researchers are investigating its safety when delivered directly to the liver through a hepatic artery infusion pump, specifically for liver cancer. The current focus is on ensuring its safety in this application.12345

Why do researchers think this study treatment might be promising?

Carfilzomib is unique because it is delivered directly to the liver through a Hepatic Artery Infusion Pump (HAIP), which allows for continuous administration right to the tumor site. This targeted delivery method is different from the standard systemic chemotherapies for liver cancer, which often affect the whole body and can cause significant side effects. Researchers are excited because carfilzomib is a proteasome inhibitor, which means it works by blocking the protein complexes that cancer cells need to survive, potentially leading to more effective and focused treatment with fewer side effects.

What evidence suggests that carfilzomib might be an effective treatment for liver cancer?

Studies have shown that carfilzomib is a promising drug with positive results in treating certain cancers. It blocks cancer cell growth by targeting parts of the cell that function as recycling centers. In other cancer types, carfilzomib has demonstrated a high success rate and has even improved survival chances in some cases. Lab tests indicate that carfilzomib has moderate effects against liver cancer cells but can significantly enhance other treatments. In this trial, participants with liver metastatic disease will receive continuous administration of carfilzomib via Hepatic Artery Infusion Pump (HAIP) to evaluate its effectiveness specifically for liver cancer.12678

Who Is on the Research Team?

JM

Jonathan M Hernandez, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults (18+) with colon, adrenal gland, or bile duct cancer that has mostly spread to the liver and who already have a working hepatic artery infusion (HAI) pump from previous treatment. Participants must be in generally good health, not pregnant, and able to use contraception.

Inclusion Criteria

I have liver-dominant metastatic cancer, with most tumors in my liver.
My cancer outside the liver has been stable for at least 6 weeks after treatment.
I have had hepatic artery infusion pump therapy and my pump is still working.
See 12 more

Exclusion Criteria

Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test at screening
History of allergic reactions to compounds chemically similar to CFZ
My cancer has recently worsened outside the liver, as shown on scans.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive continuous administration of carfilzomib via Hepatic Artery Infusion Pump (HAIP) in cycles of 28 days for up to 6 cycles

6 months
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Carfilzomib

Trial Overview

The study tests if carfilzomib—a drug usually used for other cancers—is safe when given directly into the liver through an HAI pump in people whose liver tumors returned after earlier HAI therapy. Treatment lasts about 6 months with weekly clinic visits.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: 1/Phase IExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Sorafenib and Carfilzomib Synergistically Inhibit the ... - PMC

In vitro, we found that carfilzomib has moderate anticancer activity toward liver cancer cells, but strongly enhances the ability of sorafenib to suppress HCC ...

Linvoseltamab/Carfilzomib Shows Promising Efficacy in ...

The one-year duration of response was 87%, and progression-free survival at 1 year reached 83%. “At a medium for about 15 months, the overall ...

Carfilzomib: A Promising Proteasome Inhibitor for the ...

Overall response rate was higher in the carfilzomib treatment group (19.1%) compared to control group (11.4%), which was significant (P = 0.0305) ...

Superior outcomes and high-risk features with carfilzomib ...

The ORR was 90%, with a VGPR or higher response of 69%. 3-year overall survival rate (OS): no versus yes = 62.2%

Carfilzomib prescribing patterns and outcomes for relapsed ...

Despite historical use of twice-weekly dosing, the study found no significant benefit in outcomes compared to once-weekly regimens. This research offers ...

Hepatic Artery Infusion of Carfilzomib in Participants With ...

Objective: -To establish the safety of hepatic artery infusion (HAI) of carfilzomib (CFZ) in participants with liver metastatic disease

Carfilzomib - LiverTox - NCBI Bookshelf - NIH

Hepatotoxicity is listed as a warning in the product label for carfilzomib and monitoring of serum enzymes during treatment is recommended. ...

202714Orig1s000

Nonclinical reviews state: Carfilzomib was not genotoxic in the reverse mutation bacterial test (Ames) and the mouse micronucleus test.