A PHASE-1 STUDY OF RECOMBINANT INTERFERON-GAMMA GIVEN INTRAVENOUSLY BY PORTABLE MINI-PUMP - A PRELIMINARY-REPORT

  • 1 January 1984
    • journal article
    • research article
    • Vol. 4  (6) , 469-474
Abstract
Recombinant interferon-gamma was given to patients with tumors by a 6-h i.v. infusion using a portable mini-pump, to assess the side-effects of the drug. At present, 11 patients were treated; 2 adenocarcinoma of the ovary, 3 squamous carcinoma of the bronchus, 1 adenocarcinoma of the breast, 1 adenocarcinoma of the stomach, 1 Hodgkin''s lymphoma, 1 case of 2 primaries, adenocarcinoma of the breast and ovary, and 1 adenocarcinoma of unknown origin. Two patients received 1 .times. 106 units/m2/infusion, 4 received 3 .times. 106 U/m2/inf., 3 received 6 .times. 106 U/m2/inf. and 2 received 9 .times. 106 U/m2/inf. Two further dose levels will be used in the future; 27 and 51 .times. 106 U/m2/inf. Three 6-h infusions a week were given for a 4 wk period. The major side-effects of gamma-interferon were dose-related pyrexia with rigors to which there was no tachyphylaxis, acute and chronic tiredness, nausea with or without vomiting, headache, backache and myalgia. There was also a dose-dependent immediate but mild and transient decrease in the total white cell count. All effects were transient and none were severe. I.v. infusions by mini-pumps are tolerated far better by the patients than conventional drip system and mini-pumps are the ideal way to give i.v. infusions.

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