Phase I assessment of the novel angiogenesis inhibitor DS4152 (Tecogalan Sodium) (Meeting abstract).

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Phase I assessment of the novel angiogenesis inhibitor DS4152 (Tecogalan Sodium) (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 13:A23 1994. Unique Identifier : AIDSLINE ICDB/94600020
Eckhardt SG; Burris HA; Eckardt JR; Weiss G; Rinaldi D; Barrington R; Smith L; Fields S; Kuhn J; Smith S; et al; The Cancer Therapy and Research Center, San Antonio, TX 78229

Abstract: DS4152 is a novel angiogenesis inhibitor isolated from a low molecular weight fraction of a sulfated polysaccharide produced by the bacterium Arthrobacter. Its inhibitory effect on endothelial cell migration and proliferation is thought to be mediated by the inhibition of the binding of fibroblast growth factor to endothelial cells. We are currently conducting a Phase I trial with DS4152 given every 21 days to patients (pts) with solid tumors or AIDS-related Kaposi's Sarcoma (KS). A total of 31 courses have been administered to 14 pts. (9M/5F, average age 53, median PS 1, 3 sarcoma (non-KS), 2 colon, 2 breast, 1 melanoma, 1 non-small cell lung, 1 head and neck, 1 mesothelioma and 3 AIDS-related KS). The primary dose-limiting toxicity has been prolongation of the activated partial thromboplastin time (APTT) with peak times being 1.0-4.0 times the upper limit of normal (ULN). Data are shown in a table. APTT peaked at the end of infusion and normalized within 5 hours. We were able to ameliorate this toxicity and increase the dose by prolonging the infusion time. Other toxicities included fever and chills which responded to meperidine and acetaminophen. The therapy has been fairly well tolerated and 5 pts remain on study. No objective responses have been seen to date, but 1 patient with AIDS-related KS has experienced clinical benefit. The pharmacokinetics of DS4152 are also being evaluated. Future plans include dose escalation with prolonged infusion times and altered treatment intervals.

Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Adult Dose-Response Relationship, Drug Drug Administration Schedule Female Human Infusions, Intravenous Male Middle Age Neoplasms/*DRUG THERAPY Polysaccharides, Bacterial/*ADMINISTRATION & DOSAGE Sarcoma, Kaposi's/*DRUG THERAPY Skin Neoplasms/*DRUG THERAPY ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE I
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