Vion begins phase II anticancer drug trial

The objectives of the study are to determine the response rate and toxicity of Cloretazine in patients with locally advanced or metastatic small-cell lung cancer who have either not responded to, or relapsed following initial treatment for the disease.

“We are excited to be offering this promising new therapy to our patients with small-cell lung cancer. Innovative therapies are needed for this difficult-to-treat patient population,” commented Dr Howard Burris, investigator at the Sarah Cannon Cancer Center in Nashville, Tennessee.

According to the American Cancer Society, lung cancer is the leading cause of cancer death, and patients with small-cell lung cancer represent approximately 13% of all lung cancer patients.

Small-cell lung cancer is frequently responsive to initial chemotherapy, but recurs quickly and remains difficult to treat with standard drugs. Patients with small-cell lung cancer who do not respond to standard treatment, or who suffer a relapse after treatment, have a poor prognosis and are appropriate candidates for investigational drugs.

Alkylating agents have demonstrated activity in small-cell lung cancer, and are often used as second-line treatment following cisplatin-based combinations. Cloretazine is a novel DNA-damaging alkylating agent with broad spectrum anti-tumor activity in preclinical studies. Two phase I trials have investigated the safety profile, maximum tolerated dose, and schedule for Cloretazine in solid tumors.

This new trial in small-cell lung cancer is a multi-center phase II study that expects to enroll up to approximately 90 patients.