Enrollment process for first
human study
of Endostatin™ protein begins today
BOSTON — September 28, 1999 — The enrollment process for the first clinical trial of Endostatin™ protein, an angiogenesis inhibitor that seeks to reduce tumors by cutting off their blood supply, will begin today at 8:00 a.m.
Patients seeking to participate in the trial, a Phase I study in which researchers will assess the drug’s safety and proper dosage, may call a hotline at 617-632-5100. Information about the trial, such as the schedule and the eligibility criteria, is also available at the web sites of Dana-Farber Cancer Institute (www.dana-farber.net/endostatin), Massachusetts General Hospital (www.cancer.mgh.harvard.edu) and Beth Israel Medical Center (www.bidmc.caregroup.org/endostatin/default.asp), or by fax at 1-800-772-0253.
"Given the high visibility of Endostatin™ and the small size of this study, we have done everything possible to make our procedures open, impartial and objective," said Donald Kufe, M.D., principal investigator of the study. Kufe said that the 15 to 30 patients for the Boston study will be chosen at random from those people meeting the clinical eligibility criteria.
The study is being conducted by Dana-Farber/Partners Cancer Care – a collaboration of Dana-Farber Cancer Institute, Brigham and Women’s Hospital and Massachusetts General Hospital – in conjunction with Beth Israel Deaconess Medical Center, a CareGroup hospital.
"It is important to stress that this is a Phase I clinical trial that seeks to determine dose levels for Endostatin™ treatment," said Kufe. "It may take up to a year before we complete the study, and even then, only future studies can determine the effectiveness of the drug."
The study is open to cancer patients, age 18 and over, with solid tumors for which no other treatment is known to provide a benefit. Patients with leukemia, lymphoma, myeloma or primary brain tumors are not eligible for this study.
The hotline, which is staffed by oncology nurses, will be available weekdays between 8 a.m. and 6 p.m., Eastern Standard Time. Patients will be asked a series of questions to help determine if they are clinically eligible for the trial. If the phone lines are busy, patients may obtain the eligibility screening checklist at the web sites listed above or by fax. Completed forms may be faxed to 617-632-5305.
Patients selected at random from a database of potential participants will be invited to one of the participating hospitals to be examined by a physician to determine if they are clinically eligible for the study. It is expected that the first patients will be selected in the next few weeks and that participants will begin receiving the drug shortly thereafter. The trial is likely to continue for nine months to a year.
As this is a "dose escalation" trial, people will be selected in a series of small groups starting approximately six weeks apart. People not chosen for the first group to receive the medication will remain eligible for forthcoming groups, and additional eligible people may continue to register after the first group is chosen.
While the Boston hospitals will be the first to administer the drug to patients, the study includes two other sites that will begin enrolling patients in the near future: the University of Texas M.D. Anderson Cancer Center and the University of Wisconsin Comprehensive Cancer Center. Fewer than 100 people in total are expected to receive the drug at the three locations.
Contact: Georgia Peirce, MGH Public Affairs
Additional contacts:
Patti Embry-Tautenhan (BIDMC) 617-667-4431
Vin Petrini (BWH) 617-732-5216
Steve Singer or Todd Ringler (DFCI) 617-632-4090
.
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