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

Trial Summary

What is the purpose of this trial?

This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. 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 with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma. After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.

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 data supports the effectiveness of the treatment using the Medtronic SynchroMed II programmable pump and Intera tapered catheter 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 prolonged chemotherapy in cancer patients. These systems have been used successfully in other cancers, such as colorectal and renal cancer, with good pump function and minimal complications. ^{1 2 3 4 5}

Is the Combined Infusion System for Hepatic Cancer safe for humans?

The Medtronic SynchroMed II programmable pump and similar systems have been used safely in humans for various conditions, including cancer and chronic pain. Studies show that these systems generally function well with few serious device-related adverse events, although some complications like seromas (fluid buildup), infections, and device malfunctions have been reported. Overall, these systems are considered reliable and improve quality of life for patients. ^{1 3 4 6 7}

How does the Medtronic SynchroMed II programmable pump treatment differ from other treatments for hepatic cancer?

The Medtronic SynchroMed II programmable pump offers a unique approach by providing a continuous, controlled infusion of chemotherapy directly to the liver, potentially improving quality of life and treatment duration compared to traditional methods. This system is implantable and programmable, allowing for precise drug delivery, which can be advantageous over external pumps or non-programmable systems. ^{1 2 3 4 8}

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Clinical use of a totally implantable and programmable pump for the infusion of drugs]. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Regional arterial chemotherapy of liver tumours. I. Performance comparison between a totally implantable pump and a conventional access system. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

A programmable and implantable pumping system for systemic chemotherapy: a performance analysis in 52 patients. [2017]

4. Italy 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]. [2013]

5. Italy pubmed.ncbi.nlm.nih.gov

[Function and complications of diverse totally implantable systems for continuous intra-arterial infusion of FUdR in colorectal hepatic metastases]. [2013]

6. United States 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. [2022]

7. United States 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. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

A new technique for hepatic infusional chemotherapy. [2019]