Combined Infusion System for Hepatic Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ronald DeMatteo, M.D.
Disqualifiers: Active infection, Pregnant, Breastfeeding, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
13467How 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.
12348Eligibility 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.
+2 more
Exclusion Criteria
I currently have an active infection.
Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Hepatic Artery Infusion (HAI) TherapyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hospital of the University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Ronald DeMatteo, M.D.Lead Sponsor
References
[Clinical use of a totally implantable and programmable pump for the infusion of drugs]. [2013]Totally implantable programmable systems allow preordained complex continuous infusion of drugs. Sixteen totally programmable implantable pumps (Medtronic DAD) have been implanted in fifteen advanced colorectal and renal cancer patients for continuous ia and iv sinusoidal Fudr infusion. Median duration of pump function was 125 days (range 46-468), there was observed only one case of malfunction device which required the implant of a new device, and three complications of pump pocket (seroma, hematoma and infection) without interrumption of chemotherapy for clinical causes. The use of totally implantable programmable systems provides and important clinical improvement in controlled long-term drugs administration improving quality of life and duration of chemotherapy.
Regional arterial chemotherapy of liver tumours. I. Performance comparison between a totally implantable pump and a conventional access system. [2007]Thirty-nine patients with liver tumours have been submitted to regional arterial chemotherapy by means of either totally implantable Infusaid-400 pumps (22 c.) or implantable ports (17 c.). The latter were subsequently perfused with external pumps. There was one single major operative complication and no operative deaths. Most patients underwent continuous Fudr infusion. Access related complications occurred in both groups. Treatment was stopped for access related complications in 18.4% and 29.4% of cases out of the pump and port groups respectively. In most of those cases, however, several cycles of chemotherapy had already been performed. The Infusaid-400 pumps showed a 12-month functional duration of 57% with a 13-month median, the 10-month duration of ports being 67%. The difference was not significant. The new implantable systems give better results in comparison with traditional regional access methods, the functional performances of the port systems appearing very similar to the totally implantable pumps, with an obvious advantage for the pumps as far as quality of life is concerned.
A programmable and implantable pumping system for systemic chemotherapy: a performance analysis in 52 patients. [2017]We have prospectively evaluated the performance of the implanted battery-powered Medtronic (Minneapolis) SynchroMed infusion system. Between July 1984 and July 1986, fifty-three SynchroMed pumps were implanted in 52 patients for phase I and II trials of low-dose continuous-infusion doxorubicin (N = 35) or vinblastine (N = 17). The median duration of pump function was 145 days (mean, 180; range, 20 to 787 +) and the systems infused drugs for 61% (range, 32% to 100%) of their patient implant time. During 10,045 patient days (27.5 years) of implantation, there have been no failures of the pump mechanism and pump accuracy was excellent (2.2% error rate in 256 analyzed refills). The median cost of the hospitalization for implantation was +17,140 in 14 analyzed cases. Complications requiring a second surgical procedure occurred with 13 systems (24%). Two of the complications were related to localized cutaneous hypersensitivity to vinblastine, four were directly related to system complications, and seven were secondary to implant procedure problems. Seven patients (13%) requested removal of the device after tumor progression occurred. Based on this experience, the company has made improvements in certain aspects of system design and has implemented a comprehensive user training program to minimize procedure-related problems. The Medtronic SynchroMed is an accurate and sophisticated system that allows infusion of low-dose doxorubicin and of vinblastine for prolonged periods. Extravasation of these vesicant agents must be carefully prevented. The financial cost of this implanted system may limit its use to patients with an expected survival of 5 months or longer.
[Comparison of the performance of a totally implantable pump and conventional access systems in regional arterial chemotherapy of liver tumors]. [2013]Forty-nine patients with liver tumors have been submitted to regional arterial chemotherapy by means of either totally implantable Infusaid 400 pumps (29 casse) or implantable ports (20 cases). The latter were subsequently perfused with external pumps. There was one single major operative complication and no operative deaths. Most patients underwent continuous FUDR infusion. Access related complications in the Pump and Port groups respectively included 1 and 0 malfunctions, 7 and 2 seromas, 2 and 0 pocket necroses, 8 and 10 thromboses, 2 and 4 catheter dislocations, 0 and 2 portal breakages. Treatment was stopped for access related complications in 5 and 5 patients respectively. In most of those cases, however, more than 6 cycles of chemotherapy have been performed. The Infusaid 400 pumps showed a 12-month duration of 58.4% with a 13 month median versus 17% and 9 month median of the Ports. The difference was not significant. The new implantable systems give better results in comparison with traditional regional methods; the performance of the Port systems appear very similar to the totally implantable pumps, with an obvious advantage, however, for the pumps as far as quality of life is concerned.
[Function and complications of diverse totally implantable systems for continuous intra-arterial infusion of FUdR in colorectal hepatic metastases]. [2013]Different totally implantable arterial infusion systems were compared in patients with liver metastases from colorectal cancer undergoing continuous intra-arterial infusion. Seventy-eight patients received continuous FUdR infusion using either totally implantable pumps (group a = 44 pts.) or ports fed by external portable pumps (group b = 34 pts.), and 57 patients received bolus infusion of Cisplatin (group c). Devices were cared for patency even after interruption of treatment, commonly caused by disease progression. Pocket problems most frequently occurred in group a (30%) compared to groups b (9%) and c (7%), whereas a higher incidence of catheter and infusion related problems was observed in group b (109%). System failure was recorded as a cause of interruption of treatment in two, 9, and 6 cases in groups a to c, respectively. The 12-months patency rate was 92% in group a, 24% in group b (median 9 months), and 65% in group c (median 17 months). Though implantable ports allow adequate infusion periods in most cases they seem more adequate for bolus infusions.
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]The Model 8831 Personal Therapy Manager (PTM) offers a patient-controlled analgesia (PCA) option for the SynchroMed Infusion System (Medtronic Inc., Minneapolis, MN). The safety and effective operation of the PTM activator was evaluated in 45 patients in five European centers receiving intrathecal drug infusion for the treatment of chronic pain via a SynchroMed pump. The total volume of drug delivered intrathecally over a four-week follow-up period was calculated. Adverse events were recorded and pain levels were measured via the Visual Analog pain Scale (VAS), Brief Pain Inventory, and SF-12 Quality of Life scores. Patient satisfaction with the device and its instruction manual was also assessed by questionnaire. The expected and calculated intrathecal drug volumes (and therefore drug doses) were the same, demonstrating that the device worked as intended. There were no device-related serious adverse events. Overall, 96% of patients were satisfied with the activator. Patients appreciated being able to control their pain and considered the device and its instructions easy to use. The PTM was shown to be safe and functioning properly in the intrathecal treatment of pain. The successful addition of a PCA function to the SynchroMed system may create a new standard in intrathecal pain therapy.
Assessment of telemetry and fluidic control system used in the Medstream programmable infusion system: an in vivo and in vitro study. [2014]The MedStream Programmable Infusion Pump, an intrathecal pump indicated for the treatment of chronic intractable pain and severe spasticity (CE-mark) or severe spasticity (US), has a highly accurate medication delivery (within 10% of the programmed flow rate) and is certified for use in 3-Tesla magnetic resonance imaging systems (conditional). Performance of the telemetric link between external control-unit and implanted pump was assessed in sheep (in vivo) up to 26 weeks, resulting in 1040 communication sessions. The telemetric communication envelope (communication distance and maximum antenna tilt angles) and communication duration were characterized in an in vitro test. Capacitance measurements of the piezoelectric actuator of the valve, valve flow rates, and leak rates were measured in an in vitro cyclic accelerated aging test to assess reliability of the valve over 6,200 k cycles. The pump was well tolerated in vivo; all communication sessions between control-unit and pump were successful (P = 6.889 × 10(-14)). Mean communication distance between pump and control-unit was 3.8 cm, with the maximum antenna tilt angles being 40° (θy) and 50° (θx) for all test cases; the maximum communication duration was 5.5 s. Capacitance measurements, flow rates, and leak rates were within ±10 % range up to 6,200 k cycles corresponding to approximately 10 times the valve cycles over the specified service life of the pump (8 years), except for one flow-rate value, which can be explained by the measurement setup. These results demonstrate the reliability of the telemetry link and piezoelectric valve system of the MedStream Programmable Infusion Pump.
A new technique for hepatic infusional chemotherapy. [2019]Constant-infusion intra-arterial chemotherapy is associated with a significantly greater tumor response rate and perhaps an improved survival rate. Many intra-arterial drug delivery systems have been described, the most popular of which is the implanted Infusaid pump. Unfortunately, this is an expensive device that requires considerable experience in its implantation and maintenance. This paper describes a simplified, inexpensive technique, which can comfortably and reliably provide intra-arterial hepatic chemotherapy to patients treated in most moderate-size community hospitals. Implantation requires angiography and a minor surgical procedure. Maintenance of the system is easy and inexpensive. While use of the Infusaid pump is preferable, this technique is a reasonable alternative for the following: 1) patients with very poor hepatic function, 2) patients who cannot afford the implanted pump, 3) patients who have concomitant extrahepatic tumor, 4) patients with noncolorectal metastasis to the liver, and 5) patients treated at hospitals that do not have implanted pump capabilities.