The results of the first clinical trial of a highly-publicized cancer drug designed to halt tumor growth by cutting off its blood supply indicates the medication is safe and has few side effects and that further trials are warranted.
The drug, Angiostatin, was given to patients with advanced cancer at the Kimmel Cancer Center at Thomas Jefferson University Hospital in Philadelphia who had failed prior treatments with chemotherapy.
"We're very encouraged by these results," says Robert L. Capizzi, M.D., professor of medicine at Jefferson Medical College of Thomas Jefferson University in Philadelphia, who was the principal investigator of the trial. The study was a Phase I clinical trial, which typically tests for safety and to determine how the body handles the drug - and is not necessarily aimed at measuring the effectiveness of a drug.
"We see the study as a success," says Eduardo DeMoraes, M.D., an instructor in the Department of Medicine at Jefferson Medical College. He presents the study results May 13 at the American Society of Clinical Oncology meeting in San Francisco.
In the trial, groups of 3 to 6 patients received increasing doses of drug. The study was designed to give subsequent groups of patients increasing doses, beginning at a lower safe dose that is subsequently increased in each successive group of patients. In all, 19 patients received one of five doses spanning a 16-fold range.
Each dose was given daily for 10 minutes. The doctors waited 28 days after giving a dose to determine its safety before increasing the dose for the next group.
"One of the challenges of developing a new class of drugs that has never before been given to human beings, especially drugs that inhibit blood flow to tumors without directly destroying tumor cells as occurs with chemotherapy or radiation, is to develop means for determining which patients would benefit from continued treat
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Contact: Steve Benowitz
steven.benowitz@mail.tju.edu
215-955-5291
Thomas Jefferson University
12-May-2001