Immunologic effects of AS101 in the treatment of cancer patients.
AS101 [ammonium trichloro(O,O'-dioxyethylene)tellurate] is a new immunomodulator previously shown to stimulate the production of different cytokines in vitro and in vivo. We report here our results of a phase I clinical trial conducted on 47 cancer patients with advanced malignancies. AS101 was administered intravenously at escalating doses from 1 to 10 mg/m2, twice or thrice a week. The maximal tolerated dose has not yet been determined. However, significant immunologic responses were noted at dose levels of 1-3 mg/m2 administered three times a week. At these doses statistically significant rises in gamma-interferon, natural killer cell activity, tumor necrosis factor and interleukin-2 (IL-2) levels as well as the expression of IL-2 receptors were noted. In most of the immunologic parameters the maximal response was seen at 3 mg/m2. Throughout the study toxicity was minimal. In view of these results phase II studies are currently being initiated.
Shani
A
A
Department of Oncology, Kaplan Hospital, Rehovot, Israel.
Tichler
T
T
Catane
R
R
Gurwith
M
M
Rozenszajn
L A
LA
Gezin
A
A
Levi
E
E
Schlesinger
M
M
Kalechman
Y
Y
Michlin
H
H
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004341:Drug Evaluation; D005030:Ethylenes / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000276:immunology
D000276:Adjuvants, Immunologic; D005030:Ethylenes; C054105:ammonium trichloro(dioxoethylene-O,O'-)tellurate