A unique way of delivering chemotherapy using nanoparticles appears safe and tolerable, according to early results from a phase I clinical trial. City of Hope researchers presented the findings at the 100th Annual Meeting 2009 of the American Association of Cancer Research in Denver on April 21.

Yun Yen (Photo by p.cunningham)

Yun Yen, M.D., Ph.D., Dr. & Mrs. Allen Y. Chao Chair in Developmental Cancer Therapeutics and professor in the Department of Medical Oncology & Therapeutics Research, conducted the trial, which tested the safety and tolerability of a drug called IT-101 in patients.

IT-101 is a tiny, engineered molecule called a nanoparticle that carries the powerful anticancer drug camptothecin.

In the study, 18 patients with solid tumors that failed to respond to all standard therapies were divided into two groups: one group received IT-101 infusions for three weeks in a row with one week off; the other received IT-101 every other week.

The researchers found the doses they used were safe in both regimens, but patients tolerated the drug better when they received it every other week rather than for three straight weeks.

The researchers recommended future trials use the every-other-week regimen.

“IT-101 is currently being investigated as a chronic maintenance therapy to delay disease progression after traditional chemotherapy, and our findings show that nanoparticles can be a safe delivery system,” said Yen.

Yen and his team hope IT-101 one day will let them provide patients with larger doses of chemotherapy delivered directly to tumor cells while limiting side effects that are common to treatment such as nausea and hair loss.

Yen noted that several patients showed promising responses to the nanoparticle, including one patient whose disease has not progressed in the nine months since the trial began. He cautioned that more studies were necessary before the drug’s effectiveness could be measured for certain, however.