Combined Infusion System for Hepatic Cancer

Overseen By Allie Raevsky, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ronald DeMatteo, M.D.

Disqualifiers: Active infection, Pregnant, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Every 2-12 weeks depending on pump usage

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of a new chemotherapy delivery method for individuals with liver cancer linked to colorectal cancer or intrahepatic cholangiocarcinoma. The trial employs the Medtronic SynchroMed II programmable pump and Intera tapered catheter system to deliver chemotherapy directly to the liver. Participants will have this device implanted, with regular checks on its functioning through scans and other safety measures. This trial suits adults with liver cancer whose doctors have recommended chemotherapy through this pump as a viable option. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combined infusion system is safe for hepatic artery infusion therapy?

Research shows that the Medtronic SynchroMed II pump, used with the Intera catheter, is generally safe for delivering medicine directly to the liver. Studies have found that this system effectively manages various conditions with fewer side effects than traditional methods. Testing has confirmed that the pump and catheter deliver the correct amount of medication safely.

However, some important safety points require consideration. The pump should not be implanted if an infection is present or if it is placed more than 2.5 centimeters under the skin. It is also unsuitable for individuals with very small body size. These factors are crucial to avoid complications.

In summary, research has shown that using the Medtronic pump and Intera catheter together is safe, provided certain conditions are met. Prospective clinical trial participants should discuss their specific situation with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for hepatic cancer involve systemic chemotherapy, which affects the entire body and can lead to significant side effects. The Medtronic SynchroMed II pump, however, offers a targeted approach by delivering chemotherapy directly to the liver through Hepatic Artery Infusion (HAI) Therapy. This method uses a combination of a Medtronic pump and an Intera tapered catheter to precisely administer the drug FUDR (floxuridine) to the liver, potentially reducing systemic side effects and increasing the concentration of the drug at the tumor site. Researchers are excited about this treatment because it represents a more focused way to attack liver tumors, which could lead to better outcomes and fewer side effects compared to traditional chemotherapy.

What evidence suggests that this combined infusion system is effective for hepatic cancer?

Research has shown that implantable pumps like the Medtronic SynchroMed II can effectively deliver medication. These pumps provide a continuous supply of medicine, potentially improving quality of life. In this trial, participants will receive hepatic artery infusion (HAI) therapy, where the Medtronic pump delivers chemotherapy directly to the liver through the hepatic artery. Studies have demonstrated that this technique can target liver tumors more precisely and cause fewer side effects than traditional chemotherapy. This approach aims to enhance the effectiveness of chemotherapy for treating liver cancers, including those originating in the colon or bile ducts. Ensuring the safety of this system remains a priority, but the potential for improving treatment delivery is promising. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with colorectal cancer that has spread to the liver or intrahepatic cholangiocarcinoma. Candidates should be suitable for pump chemotherapy, as determined by medical and surgical oncologists, and must consent to participate. They may have inoperable disease responding to chemotherapy or plan postoperative hepatic artery infusion.

Inclusion Criteria

Provision of signed and dated informed consent form

I am getting a pump for my inoperable cancer that responds to chemo, or I am having surgery with planned chemo via a pump afterwards.

My cancer started in the colon or rectum and has spread to the liver, or I have cancer that began in the liver's bile ducts.

Exclusion Criteria

I currently have an active infection.

Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Evaluation

Evaluation of the combined pump and catheter system using a nuclear scan to confirm functionality prior to chemotherapy infusion

1-2 weeks

Treatment

Participants receive hepatic artery infusion (HAI) of FUDR chemotherapy using the implanted pump and catheter system

Every 2-12 weeks depending on pump usage

Follow-up

Participants are monitored for safety and effectiveness of the pump/catheter combination, including routine imaging and pump volume checks

Up to 60 months or until pump removal/study withdrawal

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic SynchroMed II programmable pump

Trial Overview The study tests a Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter system for delivering chemotherapy directly into the liver. The safety of this method using FUDR (a standard chemo drug) will be monitored through nuclear scans and routine imaging over up to five years.

How Is the Trial Designed?

Group I: Hepatic Artery Infusion (HAI) Therapy Experimental Treatment 1 Intervention

Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.

Medtronic SynchroMed II programmable pump is already approved in United States, European Union for the following indications:

Approved in United States as Medtronic SynchroMed II programmable pump for:

• Colorectal cancer metastatic to the liver
• Intrahepatic cholangiocarcinoma

Approved in European Union as Medtronic SynchroMed II programmable pump for:

• Colorectal cancer metastatic to the liver
• Intrahepatic cholangiocarcinoma

Who Is Running the Clinical Trial?

Ronald DeMatteo, M.D.

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

In a study of 39 patients with liver tumors, both totally implantable Infusaid-400 pumps and implantable ports were used for regional arterial chemotherapy, showing a low major complication rate with no operative deaths.

The Infusaid-400 pumps had a 12-month functional duration of 57%, while ports had a 10-month duration of 67%, indicating that both systems are effective, but the pumps may offer better quality of life benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional arterial chemotherapy of liver tumours. I. Performance comparison between a totally implantable pump and a conventional access system. Civalleri, D., Cafiero, F., Cosimelli, M., et al.[2007]

The MedStream Programmable Infusion Pump has shown high accuracy in medication delivery, maintaining flow rates within 10% of the programmed settings, and has been successfully tested for up to 26 weeks in sheep with all communication sessions between the pump and control unit being successful.

The pump's telemetry and valve systems demonstrated reliability over extensive testing, with capacitance, flow rates, and leak rates remaining stable over 6,200 cycles, indicating it can effectively function for its intended service life of 8 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of telemetry and fluidic control system used in the Medstream programmable infusion system: an in vivo and in vitro study. Bork, T., Crivelli, R., Tardy, Y., et al.[2014]

The Medtronic SynchroMed infusion system demonstrated excellent accuracy and reliability, with no pump mechanism failures over 10,045 patient days and a low error rate of 2.2% in drug delivery.

While the system allows for effective long-term infusion of low-dose chemotherapy drugs like doxorubicin and vinblastine, complications occurred in 24% of cases, and the high cost of implantation may restrict its use to patients with longer expected survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A programmable and implantable pumping system for systemic chemotherapy: a performance analysis in 52 patients. Vogelzang, NJ., Ruane, M., Ratain, MJ., et al.[2017]

In a study of 49 patients with liver tumors receiving regional arterial chemotherapy, both totally implantable Infusaid 400 pumps and implantable ports were used, showing a low complication rate with only one major operative complication and no deaths.

The Infusaid pumps had a higher 12-month treatment duration (58.4%) compared to the ports (17%), although the difference was not statistically significant, indicating that both systems are effective but the pumps may offer better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the performance of a totally implantable pump and conventional access systems in regional arterial chemotherapy of liver tumors]. Simoni, G., Bignami, P., Civalleri, D., et al.[2013]

The Model 8831 Personal Therapy Manager (PTM) was evaluated in 45 patients and demonstrated effective operation in delivering intrathecal pain medication, with no serious device-related adverse events reported.

96% of patients expressed satisfaction with the PTM, highlighting its ease of use and the benefit of patient-controlled pain management, suggesting it could set a new standard in intrathecal pain therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-controlled Analgesia in Intrathecal Therapy for Chronic Pain: Safety and Effective Operation of the Model 8831 Personal Therapy Manager with a Pre-implanted SynchroMed Infusion System. Maeyaert, J., Buchser, E., Van Buyten, JP., et al.[2022]

In a study of 78 patients with liver metastases from colorectal cancer, totally implantable pumps (group a) showed a high 12-month patency rate of 92%, significantly better than the 24% rate for external portable pumps (group b).

While totally implantable pumps had more pocket problems (30%), external pumps had a higher incidence of catheter and infusion-related issues, indicating that while implantable systems are effective for continuous infusion, they may not be the best choice for all types of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Function and complications of diverse totally implantable systems for continuous intra-arterial infusion of FUdR in colorectal hepatic metastases]. Civalleri, D., Bignami, P., De Cian, F., et al.[2013]

Constant-infusion intra-arterial chemotherapy shows a significantly greater tumor response rate and potentially improved survival, making it an effective treatment option.

The paper presents a simplified and cost-effective technique for administering intra-arterial hepatic chemotherapy, which is suitable for patients who cannot use the more expensive Infusaid pump due to various medical or financial reasons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new technique for hepatic infusional chemotherapy. Pagana, TJ.[2019]

In a study involving 15 patients with advanced colorectal and renal cancer, the use of totally implantable programmable pumps for continuous drug infusion showed a median function duration of 125 days, indicating reliable long-term drug delivery.

The system demonstrated a low complication rate, with only one device malfunction and three minor complications, suggesting that these pumps can enhance the quality of life for patients undergoing chemotherapy without significant interruptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical use of a totally implantable and programmable pump for the infusion of drugs]. Balletto, N., Cavallini, M., Cortesi, E., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04684862

NCT04684862 | Infusion System for Hepatic Cancer In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/90/NCT04276090/Prot_SAP_ICF_001.pdf

Document Coversheet This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy ...

3. withpower.com withpower.com/trial/phase-cholangiocarcinoma-1-2021-4159c

Combined Infusion System for Hepatic Cancer Research shows that implantable pumps like the Medtronic SynchroMed II are effective for continuous drug infusion, improving quality of life and allowing ...

4. omicsdi.org omicsdi.org/dataset/ecrin-mdr-crc/2362010

2362010 - Infusion System for Hepatic Cancer Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal. DISEASE(S): Intrahepatic ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38006531/

Phase I Safety and Feasibility Pilot of Hepatic Artery Infusion ... The trial examined the safety of the hybrid Codman catheter/Medtronic SynchroMed II pump (hCMP) combination, defined as successful completion of one cycle of ...

6. medtronic.com medtronic.com/in-en/patients/treatments-therapies/drug-pump-severe-spasticity-full-prescribing-information/important-safety-information.html

Important Safety Information | SynchroMed II Drug Pump Contraindications: System implant is contraindicated in the presence of an infection; implant depth greater than 2.5 cm below skin; insufficient body size; and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140032B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The objective was to demonstrate that the Model 10642. Implantable Intravascular Catheter is safe when used with the Medtronic SynchroMed II.

8. medtronic.com medtronic.com/en-us/healthcare-professionals/products/neurological/drug-infusion-systems/synchromed-ii-intrathecal-pump.html

SynchroMed™ II Intrathecal Pump Targeted drug delivery is a safe, proven, and effective way to manage chronic pain with fewer side effects and lower doses than systemic medication.1. The ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4218763/

Clinical Accuracy and Safety Using the SynchroMed II ... We evaluated the infusion accuracy and device-related safety of implantable drug infusion pumps in subjects with chronic pain or severe spasticity.