Iontophoresis Chemotherapy for Pancreatic Cancer

This trial explores a new method for treating pancreatic cancer by delivering chemotherapy directly to the tumor using a device. Researchers aim to determine if this approach is safe and causes fewer side effects than traditional IV chemotherapy. Participants will have a device placed on their pancreas and receive treatments once or twice a week for eight weeks. The trial seeks individuals with pancreatic cancer that hasn't spread and can't be surgically removed, who have already tried other chemotherapy treatments, including Gemcitabine. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Research has shown that the ACT-IOP-003 device, which delivers gemcitabine directly to the pancreas, is generally safe and well-tolerated. This method targets the tumor more precisely and reduces the amount of gemcitabine entering the bloodstream. Consequently, patients may experience fewer side effects compared to traditional intravenous methods.

Earlier tests demonstrated that using a small electrical charge to deliver the medicine (known as iontophoresis) resulted in much higher concentrations of gemcitabine at the tumor site while maintaining low overall levels in the body. This targeted delivery may lead to fewer side effects, as the drug does not spread widely throughout the body.

Researchers are excited about the iontophoresis chemotherapy for pancreatic cancer because it offers a novel way to deliver gemcitabine, a standard chemotherapy drug. Unlike traditional methods where gemcitabine is administered intravenously, this treatment uses a special device to deliver the drug directly through the skin using electrical currents, potentially increasing its concentration at the tumor site and minimizing systemic side effects. The trial has two arms: one where gemcitabine is delivered once weekly, and another where it is delivered twice weekly, allowing researchers to compare dosing frequencies for optimal effectiveness. This innovative approach could lead to more efficient and targeted cancer treatment, potentially improving patient outcomes.

This trial will evaluate the ACT-IOP-003 device for delivering gemcitabine directly to the pancreas to treat pancreatic cancer. Participants will join one of two cohorts: Cohort 1 will receive gemcitabine via the device once weekly, and Cohort 2 will receive it twice weekly, both for 8 weeks. Research has shown that the ACT-IOP-003 device may deliver high amounts of the drug directly to the tumor, potentially enhancing its effectiveness. It also reduces the drug's presence in the bloodstream, which could lessen side effects commonly associated with intravenous delivery. Early results from animal studies suggested that this targeted delivery can shrink the tumor more effectively. These findings are promising, but further research in humans is necessary to confirm these effects.¹⁴⁵⁶⁷