A vaccine for melanoma still eludes scientists, but a surprising group ofpeople _ men _ may be a step closer to one.At the annual meeting of the American Society of Clinical Oncology(ASCO) in Dallas this week researchers reported inconclusive resultsfrom a Phase III trial of vaccinia melanoma oncolysate (VMO), a skincancer vaccine derived from multiple melanoma cell lines.However, they noted a distinct response pattern in one subgroup: menunder the age of 57 who had disease that affected one to five lymphnodes. This result was unexpected, given the fact that men usuallyrespond less well to melanoma therapy than do women.While emphasizing that results of the trial were not clinicallysignificant, the researchers said these interesting patterns should beexplored to determine what the next step should be. The trial wassupported by the National Cancer Institute _ the first time it hasfunded a cancer vaccine trial. The 250 patients, enrolled at 11 sites, hadStage II melanoma which had spread to the lymph nodes. Followingsurgery, all were free of disease when the trial began. Stage II patientswere selected because they are at highest risk of recurrence of thedisease but still have functioning immune systems.In other news from the ACSO conference:y Gliadel, a surgically implanted biodegradable polymer disc developedby Guilford Pharmaceuticals, of Baltimore, proved effective indelivering carmustine, a chemotherapy agent, safely and effectivelyagainst malignant brain tumors in a Phase III trial, researchers reported.The implant released the drug at the brain tumor site for three weeks,without exposing the rest of the body to toxic chemotherapy. Theresearchers said the median survival rate of the 110 patients whoreceived the agent this way was 31 weeks, compared to 23 weeks forthe 112 patients who received placebo polymers. The randomized,placebo-controlled trial was conducted at 27 medical centers in theU.S. and Canada.y Researchers reported positive results of a Phase III trial ofAmifostine, U.S. Bioscience's cytoprotective agent to limit the toxiceffects of chemotherapy and radiation associated withcyclophosphamide and cisplatin.The trial involved 250 patients with advanced ovarian cancer at 52centers. The results presented were based on a complete analysis of thefirst 200 patients enrolled.Ten percent of patients given all three drugs experienced neutropenia,fever, or infection compared to 27 percent who received onlycyclophosphamide and cisplatin. In patients given the triplecombination, improvements were noted in length of hospital stay,delayed chemotherapy, and other measures. Pathological response rateswere reported equivalent. Median survival rates did not differ betweenthe two groups.U.S. Bioscience filed a new drug application for Amifostine inSeptember 1991, based on an interim analysis of 120 patients. TheFDA , however, required the company to provide additional data,including information on survival rates. Alison Ayers, a spokeswomanfor U.S. Bioscience, said the extended trial, which completedenrollment in March 1994, has provided the company with theinformation it needs to respond to the FDA's questions.y Medarex Inc., of Princeton, N.J., reported that MDX-210, itsbispecific antibody therapeutic for breast and ovarian cancer, showedevidence of anti-tumor activity in a recently concluded Phase I/IIclinical trial. The trial involved 15 patients who had failed multipleregimens of chemotherapy or hormonal therapy. They received a singledose of MDX-210. Two of the 10 patients with measurable tumors hadclinical responses. The drug was well tolerated.y Cell Therapeutics Inc., of Seattle, reported that in a Phase I multi-center trial of its small molecule compound, lisofylline (CT-1501R),patients with higher blood levels of lisofylline experienced less toxicityfrom Interleukin-2 therapy than those with lower blood levels. The trialinvolved 34 patients with advanced renal cancer or malignantmelanoma.
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