Dateline DFCI
All eyes on Dana-Farber as Endostatin™ study continues
Donald Kufe, M.D.
In one of the most closely watched cancer studies in recent years, the first clinical trial of Endostatin — a substance that, in mouse studies, has caused some tumors to shrink by cutting off their blood supply — has begun and is running smoothly.
Dana-Farber and the other affiliates of Dana-Farber/ Partners CancerCare — Brigham and Women's Hospital and Massachusetts General Hospital — plus Beth Israel Deaconess Medical Center, were the first sites to enroll patients in the clinical trial, a Phase I study that will determine the safe dosage of the drug.
The study, is being sponsored by Endostatin's manufacturer, EntreMed, of Rockville, Md., and the National Cancer Institute, and also involves two additional sites: M.D. Anderson Cancer Center in Houston and the University of Wisconsin Comprehensive Cancer Center. Dana-Farber's participation in the trial is being led by Donald Kufe, M.D., chief of Cancer Pharmacology.
Because of the extensive press coverage Endostatin has received — in the New York Times, national television and radio networks, and local media outlets — a hotline staffed by specially trained oncology nurses was established at the Institute last September for patients or their physicians to register. A new database was created for patients eligible for the trial, and an outside firm was hired to randomly select the participants.
Nearly 100 patients are expected to participate across the country — 15-30 at Dana-Farber and its affiliates. Registration will continue throughout the trial, which began in October and will continue for nine to 12 months.
Endostatin was discovered in the laboratory of Judah Folkman, M.D., of Children's Hospital, and has received intense press coverage because of its success in shrinking tumors in mice. Known as an "angiogenesis inhibitor" because of its ability to choke off tumors' blood supply, Endostatin is one of several such substances under study.
