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NATIONAL CANCER INSTITUTE EXPECTS FIVE ANTI-CANCER IND APPROVALS

Executive Summary

NATIONAL CANCER INSTITUTE EXPECTS FIVE ANTI-CANCER IND APPROVALS by the end of this year, NCI Division of Cancer Treatment Director Bruce Chabnertold the National Cancer Advisory Board at its meeting in New York City Dec. 8. The five NCI compounds are: deoxyspergualin, oxantrazole, fazarabine, chloroquin-oxaline sulphonimide, and 4-ipomeanol. Chabner also predicted that IND status would soon be granted to the anti-AIDS agent dideoxycytidine, which he said would be "licensed to industry in the next six weeks." Chabner reported that to date, "about six patients" have been enrolled in an NIH clinical trial testing dideoxycytidine against AIDS. In the area of interleukin-2 and lymphokine-activated killer cells (LAK) cancer therapy, Chabner presented results from ongoing intramural and extramural clinicals. He reported that in the NCI trials, conducted by Clinical Center surgery chief Steven Rosenberg, 11 of 36 renal-cell cancer patients have responded to the treatment so far. Commenting on the response differences observed between the NCI and extramural studies, Chabner explained that patients in the NIH studies "primarily have multiple small pulmonary lesions, while the extramural patients have pulmonary and bulky, intra-abdominal disease." He speculated that the therapy may not be as effective against "bulky abdominal disease" as it is against more disseminated lung cancer. All patients in the current clinicals are in advanced stages of disease. Results for other sites were comparable in both the NCI and the extramural trials, with 24% and 18% response rates, respectively, in melanoma patients. For colon cancer, NIH-treated patients showed a 13% response rate, while 12% of those in the extramural group responded to the therapy. Rosenberg, et al, published a study of recombinant interleukin-2 in the treatment of 10 patients with disseminated cancer in the Dec. 12 issue of the Journal of the American Medical Association. Investigators reported that three of six patients with melanoma experienced an objective regression and there was no response to treatment in patients with colorectal or ovarian cancer. "Two patients with inital objective regressions who subsequently developed progression were re-treated and one sustained a second partial response," the researchers stated. "Responses lasted 1, 3, and 7 months without additional treatment." They also stated that "progressive shrinkage of tumors for three to six months after the conclusion of therapy has been noted in two patients." In an accompanying editorial, Charles Moertel, MD, Mayo Clinic, asserted that "IL-2 therapy as administered in these studies is associated with unacceptably severe toxicity and astronomical costs. These are not balanced by any persuasive evidence of true net therapeutic gain." He concluded that "this specific treatment approach would not seem to merit further application in the compassionate management of patients with cancer."
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