Description: The majority of anti-cancer drugs are administered intravenously. Estimates of the frequency of extravasation of these drugs vary widely, ranging from 0.5% to more than 6%. The severity of the injury resulting from extravasation is dependent on the specific drug administered and its concentration, the amount of drug extravasated, the length of tissue exposure to the drug and the site of extravasation. The drugs associated with severe local necrosis are: Chromomycin A, Dactinomycin, Daunorubicin, Doxorubicin, Mechloretamine, Mithramycin, Mitomycin C, Streptozotocin, Vinblastine and Vincristine. Extravasation injury is most commonly caused by the anthracyclines, Daunorubicin and Doxorubicin. Necrosis may develop within days after the extravasation but necrotic ulcers usually develop over 7 to 10 days after the extravasation, sometimes enlarging over several months thereafter. Currently there is no consensus as to what should be done once extravasation has occurred. Antidotal therapy is in dispute and some clinicians maintain that the area must be excised and grafting done immediately.

While studying the effect of 365 nm light on the activity of Doxorubicin, the inventor found that, under certain conditions, the cytotoxic activity of the drug was negated by the light. Some of these early findings were published (Bomgaars, et. el., Cancer Chemother Pharmacol 40: 506-512, 1997), and a patent entitled "Formulations of Vesicant Drugs and Methods of Use Thereof" was filed, and has subsequently issued. In summary, the patent is for a novel formulation of anti-cancer drugs with Riboflavin (Vitamin B2) and other components, that do not interfere with cytotoxic (anti-cancer) activity of the drugs, but allow their expedient inactivation by illumination with a 365 nm light source. The inventor's in vitro studies show that with this light, at energies that do not affect cell growth, he can destroy the drug in a process that has a half-time of less than one minute. The value of this invention stretches much further than its possible role in the prevention of extravasation injury: (i) For medico-legal reasons, the ability to prevent this serious side effect of anti-cancer drug treatment, might make the novel formulation of these drugs the only clinically sound way of using the drugs and (ii) Many of these anti-cancer drugs are now generic. The novel formulation might allow the vendors of these anti-cancer drugs to increase their value with renewed patent protection.

Technology Status: Further studies are underway. A paper describing the invention was published in Cancer Chemother Pharmacol 40: 506-512. Additional data was recently added to a CIP patent application.

Patent Status: U.S. Patent No. 5,780,446; U.S. and foreign patents

OTA: 96-30 Reviewed: October 4, 1996.