M9241 + HAIP Chemotherapy for Liver Cancers
Palo Alto (17 mi)Overseen byJonathan M Hernandez, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Background:
One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\<TAB\>
Objective:
To see if treatment with HAIPs to deliver liver-directed chemotherapy in combination with PDS01ADC is effective for certain cancers.
Eligibility:
People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Pregnancy test (if needed)
Tumor biopsy (if needed)
Electrocardiogram
Computed tomography (CT) scans
Participants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.
Participants will have chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will get systemic chemotherapy through an IV or mediport every 2 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.
Participants will have 2 study visits each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.
Participants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.
Is the treatment M9241 + HAIP Chemotherapy for Liver Cancers promising?Yes, the treatment using the Hepatic Artery Infusion Pump (HAIP) is promising because it is an advanced therapy for liver cancers, especially when other treatments are not possible. It has shown effectiveness in treating liver metastases and is being used more frequently due to its potential benefits.12345
What safety data is available for the M9241 + HAIP chemotherapy treatment for liver cancers?The safety data for the M9241 + HAIP chemotherapy treatment primarily involves the use of the hepatic artery infusion pump (HAIP) in treating liver metastases. Studies have explored the short-term risks of concurrent procedures with HAIP placement, the safety and feasibility of initiating HAIP chemotherapy programs for unresectable colorectal liver metastases, and outcomes following different methods of HAIP placement. While HAIP has been associated with improved outcomes, its use has fluctuated due to complications and limited survival benefits in the past. Current research is focused on understanding its role in modern systemic therapies, especially for chemotherapy-resistant cases.12345
What data supports the idea that M9241 + HAIP Chemotherapy for Liver Cancers is an effective treatment?The available research shows that the hepatic artery infusion pump (HAIP) chemotherapy, which is part of the M9241 + HAIP treatment, has been used effectively for liver metastases, particularly from colorectal cancer. Studies indicate that HAIP can improve outcomes for patients with liver metastases that cannot be surgically removed. However, the research primarily focuses on colorectal liver metastases, and there is limited information specifically about its effectiveness for liver cancers in general. Therefore, while HAIP shows promise, more specific data on M9241 + HAIP for liver cancers is needed to fully support its effectiveness.12345
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents or have previously received rIL-12. It's best to discuss your current medications with the trial team to ensure compatibility with the study requirements.
Eligibility Criteria
Adults with bile duct cancer confined to the liver or colorectal cancer that has spread to the liver. They must be able to handle chemotherapy, agree to use effective contraception, and not breastfeed if applicable. HIV-positive individuals can join if their viral load is undetectable.Inclusion Criteria
I can undergo chemotherapy with specific drugs for my colorectal or intrahepatic cholangiocarcinoma.
I am 18 years old or older.
My liver cancer cannot be fully removed or treated in one procedure.
My condition cannot be treated with surgery.
I am HIV-positive with an undetectable viral load.
Exclusion Criteria
I have not had a stroke, heart attack, severe heart failure, or serious heart rhythm problems in the last 6 months.
I have an active Hepatitis B or C infection.
I have active bowel disease with poor blood supply.
I have a history of serious infections like tuberculosis.
I do not have conditions causing significant tissue death unrelated to cancer.
I have previously received rIL-12 treatment.
I have had radiation therapy to my liver.
I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.
I am allergic to certain medications similar to the study drug.
Treatment Details
The trial tests M9241 combined with HAIP-delivered chemo (Floxuridine) and systemic therapy (5-Fluorouracil, Oxaliplatin, Leucovorin for colorectal; Gemcitabine for bile duct). Participants will receive treatments biweekly until disease progression or unacceptable side effects occur.
2Treatment groups
Experimental Treatment
Group I: 2/HAIP +PDS01ADC+GemOxExperimental Treatment9 Interventions
PDS01ADC+HAIP FUDR and Dexamethasone chemotherapy in combination with GemOx
Group II: 1/ HAIP +PDS01ADC+FOLFOX or FOLFORIExperimental Treatment8 Interventions
PDS01ADC+HAIP FUDR and Dexamethasone chemotherapy in combination with FOLFOX or FOLFIRI
Find a clinic near you
Research locations nearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
References
Hepatic artery infusion pump in the treatment of liver metastases. [2018]Hepatic artery infusion pump (HAIP) use in chemotherapy started in the 1960s as a way to treat liver metastases that were not amendable to locoregional therapy or surgical resection. Because of complications and limited survival benefit, the use of HAIPs fell out of favor. A resurgence has occurred in the use of these pumps, but limited information is available in the literature guiding nursing care of these patients.
Robotic hepatic arterial infusion pump placement. [2018]Hepatic artery infusion pump (HAIP) placement is associated with improved outcomes in the treatment of colorectal liver metastases (CRLM). In this study, we examined outcomes following robotic HAIP placement, which were compared with open and laparoscopic placement.
Short-Term Risk of Performing Concurrent Procedures with Hepatic Artery Infusion Pump Placement. [2021]Hepatic artery infusion pump (HAIP) chemotherapy is an advanced cancer therapy for primary and secondary hepatic malignancies. The risk of concurrent hepatic and/or colorectal operations with HAIP placement is unknown. Our objective was to characterize the short-term outcomes of concurrent surgery with HAIP placement.
Safety and feasibility of initiating a hepatic artery infusion pump chemotherapy program for unresectable colorectal liver metastases: A multicenter, retrospective cohort study. [2022]Hepatic artery infusion pump (HAIP) chemotherapy is a specialized therapy for patients with unresectable colorectal liver metastases (uCRLM). Its effectiveness was demonstrated from a high volume center, with uncertainty regarding the feasibility and safety at other centers. Therefore, we sought to assess the safety and feasibility of HAIP for the management of uCRLM at other centers.
Salvage regional therapy using hepatic artery infusion pump in unresectable chemotherapy resistant colorectal liver metastases. [2022]Little is known about the influence of hepatic artery infusion pump (HAIP) therapy in the setting of chemotherapy resistant hepatic disease in the era of modern systemic therapies.