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[Phase-1 study of the tolerance for increasing doses of recombinant human alpha 2 interferon in patients with advanced cancer].
- Source :
-
Bulletin du cancer [Bull Cancer] 1984; Vol. 71 (1), pp. 40-9. - Publication Year :
- 1984
-
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.
- 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
Subjects
Details
- Language :
- French
- ISSN :
- 0007-4551
- Volume :
- 71
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Bulletin du cancer
- Publication Type :
- Academic Journal
- Accession number :
- 6713113