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| Vol. 21, No. 20 |
| November 1, 1999 |
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Phase I Endostatin Trial Researchers at The University of Texas M. D. Anderson Cancer Center have urged cancer patients to continue therapies outlined by their physicians rather than hold out hope for treatment with EndostatinTM, the much-publicized anti-angiogenesis drug shown to be effective in treating tumors of laboratory mice. "We are years away from knowing what benefit - if any - this drug will have in humans with cancer," explained Dr. James Abbruzzese, chairman of the department of gastrointestinal medical oncology and digestive diseases and one of the lead investigators conducting the Phase I study of the Endostatin protein at M. D. Anderson. "We are discussing the upcoming study in response to the extraordinary demand for information from the public and from the news media," he said. "This Phase I clinical trial is designed to study the safety of the drug and the dose at which it should be given. Endostatin is not yet proven, and we don't want to do anything to raise false hope among persons with cancer who are already receiving standard therapies or other investigational therapies that may be of greater benefit." Dr. Abbruzzese and principal investigator Dr. Roy Herbst, assistant professor of thoracic/head and neck medical oncology, met with reporters to brief them on plans for the National Cancer Institute-sponsored study, which is due to begin within the next two to three weeks. The researchers emphasized that only three or four patients will begin the study in the first few weeks, and it may take 18 months or longer to fill the 30 slots available. As with many patients enrolled in a Phase I clinical trial, individuals enrolled in this study will be selected from among M. D. Anderson patients, they said. Selection will be made based upon the ease of tumor biopsy, individual performance status, disease site and order of evaluation. Eligible patients must be 18 years of age, they must have failed standard therapies and be able to stay in Houston for the duration of the study for frequent monitoring. This is the first Phase I trial requiring regular biopsies. Researchers emphasized that no new patients will be accepted at M. D. Anderson specifically for the Endostatin study. M. D. Anderson is employing its usual process for accepting any new patients, they said, which means new patients must meet the medical criteria outlined by individual clinics. Once referred, new M. D. Anderson patients are evaluated by physicians in their disease specialty who will consider all viable treatment options. Referrals to available clinical studies are made by M. D. Anderson physicians. "At this time we are considering the first three or four patients for the Endostatin study," Dr. Herbst explained. "We will begin with a relatively low dose of the drug, and after four weeks' time, we will do extensive testing to examine the toxicity of that dosage before selecting the next few patients." The most likely tumor sites to be considered for the trial will be tumors of the breast and head and neck, he said, because of the typically easy accessibility of those tumors for biopsy. "We intend to treat this Phase I trial like all of our others, offering it to patients when it is a good option," explained Dr. Rebecca Pentz, associate professor of clinical ethics. "It's important that all patients talk with their physicians about the range of treatment options for their disease, whether they are newly diagnosed or already under treatment. "Patients should not forego their current treatment regimen in the belief that Endostatin will offer something curative," she emphasized. Endostatin is one of several "anti-angiogenesis" drugs that work to kill tumors by cutting off their blood supply. It was discovered three years ago in the laboratory of Dr. Judah Folkman at Children's Hospital in Boston and is being developed by EntreMed, Inc. An article about Endostatin published May 3, 1998, in The New York Times generated significant national media attention and public interest, especially among persons with cancer. The following March the National Cancer Institute announced that M. D. Anderson and the University of Wisconsin would conduct the first two clinic al studies of Endostatin in humans. Since then, M. D. Anderson has been deluged with telephone calls, mail and electronic correspondence from patients eager to enroll in this trial. More recently, another study is under way at Dana-Farber Cancer Institute in Boston, generating several thousand public inquiries. "We know we can successfully treat cancer in mice with Endostatin, but cancer in people is considerably different," cautioned Dr. Abbruzzese. "Every successful cancer treatment available today has its roots in laboratory studies. The most promising basic science research evolves into animal studies and then human studies. A Phase I trial is only the beginning of the process of clinical study to examine if a potential therapy is effective in patients. It will be years before we can demonstrate the benefit of any new treatment." - From The University of Texas M. D. Anderson Cancer Center
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