1. [Phase-1 study of the tolerance for increasing doses of recombinant human alpha 2 interferon in patients with advanced cancer].
- Author
-
Bretaudeau B, Palangie T, Giralt E, Jouve M, Pouillart P, Falcoff E, Fridman WH, Magdelenat H, Derstepani L, and Laurent T
- Subjects
- Adult, Aged, Breast Neoplasms therapy, Dose-Response Relationship, Drug, Drug Evaluation, Drug Tolerance, Female, Humans, Immunity drug effects, Interferon Type I adverse effects, Interferon Type I blood, Kidney Neoplasms therapy, Kinetics, Male, Melanoma therapy, Meningeal Neoplasms therapy, Middle Aged, Neoplasm Metastasis, Neoplasms blood, Neoplasms immunology, Sarcoma therapy, Interferon Type I administration & dosage, Neoplasms therapy
- Abstract
Thirteen patients with malignant tumors were entered into a phase I trial with recombinant DNA human alpha 2 interferon (IFN alpha 2). The patients were given I.M. escalating doses of IFN alpha 2 ranging from 1-10(6) to 200-10(6) IU with a 72 hours washout between injections. In the majority of the patients, subjective symptoms were noted: fever, headache, chills, nausea, myalgias. Asthenia, anorexia, drowsiness appeared after the highest doses and disappeared without any sequellae. Leucopenia and thrombopenia were seen in 11 out of 13 patients. Hepatocellular toxicity was observed in 9 cases. Cardiac and vascular functions were not impaired by IFN alpha 2. The pharmacokinetic studies showed a maximum serum concentration between 4 and 6 hours after injection and the peak value was directly proportional to the dose. No neutralizing INF alpha 2 serum factor was detected during the treatment. The peak value for serum beta 2 microglobulin occurred 48 hours after and the N.K. activity was variably modified by IFN alpha 2 injections. A major clinical response was observed in 1 case, a minor response in 3 cases and a stabilisation of the disease in 4 cases.
- Published
- 1984