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M. D. Anderson Finds Endostatin is Safe Two Patients Show Slight Improvement on Drug

M. D. Anderson Finds Endostatin is Safe Two Patients Show Slight Improvement on Drug
M. D. Anderson News Release 05/13/01

Final results from the Phase I trial of Endostatin at The University of Texas M. D. Anderson Cancer Center show that the anti-angiogenic drug was safe and reduced blood flow in patients. Though there was some shrinkage of tumors among participants, and two patients showed encouraging results.

The results of the Phase I trial at M. D. Anderson were presented at the 37th annual meeting of the American Society for Clinical Oncology in San Francisco by Dr. Roy S. Herbst. 

While M. D. Anderson investigators remain cautious about the future of Endostatin -- an anti-angiogenic drug that has generated national publicity and great public interest for the last three years -- they report that all 25 study patients tolerated the drug well, with few toxic side effects.  Two patients showed evidence of some tumor shrinkage, said researchers.

"This Phase I trial of Endostatin was a successful one at M. D. Anderson if you keep in mind the goals of a Phase I trial," said Dr. Herbst, assistant professor of thoracic/head and neck medical oncology and assistant professor in cancer biology.  "We not only accomplished the goal of determining the safety of the drug, but also learned more about the pharmacology of the drug and how the body reacts to Endostatin. Using Positron Emission Tomography (PET) scans, we were able to see decreases in blood flow with increasing doses of the drug.  We see promise for this drug in future trials."

According to Dr. Herbst, the doses were gradually increased and administered with intravenous infusions.  During the trial, in addition to the regular biopsies, patients had regular Computerized Tomography (CT) and PET scans.  These diagnostic tests, plus ongoing pharmacologic tests and physical examinations, helped researchers determine the biologic activity of the drug through measurement of blood flow and metabolic activity within tumors, and monitor patient's reactions to the drug, according to Dr. Herbst.

The M. D. Anderson Phase I trial included patients with varied diagnoses, including breast cancer, melanoma, head and neck cancer, colon cancer, renal cell carcinoma (a cancer of the kidney) and sarcoma. 

All participating patients were selected for the study from among current M. D. Anderson patients.  Selection of patients was based upon ease of tumor biopsy, individual performance status, disease site and order of evaluation.  All the patients had failed previous standard treatments or had no standard therapy for their disease.  Patients were required to have frequent tumor biopsies to study the biological effects of the drug, so all patients remained in Houston for the duration of the trial.

M. D. Anderson started its first patient on the Endostatin trial Nov. 3, 1999.

The Phase I trials at M. D. Anderson and the other sites were sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA).  Dr. James L. Abbruzzese, professor and chairman of the Department of Gastrointestinal Medical Oncology and Digestive Diseases at M. D. Anderson, is the director of the NCI grant for the trial.

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