[Continuous infusion of natural interleukin 2 (n IL-2) in treatment of malignant diseases: phase I study].
This is the first report of a phase I study with n-IL 2. N-IL 2 shows a higher biological activity and different immunomodulatory effects compared to recombinant IL 2. 14 patients (9 male, 5 female) entered our phase I study with continuous i.v. n-IL 2 with a median age of 40 years (range 4-65), including 4 children. The study design was a dose rising continuous iv infusion over 5 days with a starting dose of 1 x 10(6) U n-IL 2 up to 6 x 10(6) n-IL 2 over 24 h. In 2 of 16 regimen with n IL-2 there was a dose reduction and in 6 there was an interruption necessary. In 2 patients there was only a dose reduction necessary because of thrombocytopenia and hypotension. In 6 patients n-IL 2 had to break the continuous infusion. Reasons were an increasing BUN, respiratory insufficiency, thrombocytopenia, neurological symptoms and increasing liver enzymes. The 4 children developed an other side effect profile with edema of the face, abdominal cramps and thrombocytopenia. During the study no intensive care was necessary. The most common side effects were erythema, fever, nausea, dyspnea and hypotension. There was no complete remission, 21.5% of the patients had a partial remission, 7% showed no change and 71.5% had a progression. There were no significant differences in toxicity and response was comparable to studies using continuous r IL-2.
Lenz
H J
HJ
Abt. II. Tübingen Medizinische Universitätsklinik.
Brunner
T
T
Dopfer
R
R
Schlag
H
H
Ehninger
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*
D007376:Interleukin-2
Kontinuierliche Infusion von natürlichem Interleukin 2 (n IL-2) zur Behandlung maligner Erkrankungen: Phase-I-Studie.