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A phase I trial with recombinant interferon γ (Roussel UCLAF) in advanced cancer patients
- Source :
- Cancer Immunology, Immunotherapy. 32:67-70
- Publication Year :
- 1990
- Publisher :
- Springer Science and Business Media LLC, 1990.
-
Abstract
- A total of 29 patients with advanced malignancy were treated with recombinant interferon gamma (rIFN gamma, specific activity = 2.10(7) units/mg, purity greater than 95%) given by intravenous bolus at doses escalating from 0.01 mg/m2 to 5 mg/m2 (2 x 10(5) - 10(8) IU/m2) in nine successive steps (at least 3 patients/step). Injections of rIFN gamma were repeated every 72 h for 15 days. Toxicity was evaluated according to the WHO scale. Fever and chills occurred in all patients treated without clear dose effect. Nausea and vomiting appeared at the fifth dose level and their frequency seemed to be dose-related. Cardiovascular side-effects (first-degree atrioventricular reversible block) were observed at the 2 mg/m2 and 5 mg/m2 levels (3 patients). Hematological toxicities were mild (2 grade 1 and 1 grade II cases of granulocytopenia). Minor biological modifications included a transitory rise in hepatic enzymes (12 patients), which correlated with the presence of liver metastasis. Hypocholesterolemia was observed in 18 patients. The appearance of antibodies against rIFN gamma was not detected. One partial clinical response was observed in a patient receiving 2 mg/m2. During rIFN gamma therapy this patient had the highest scores in this series for peripheral T lymphocytes with an activated phenotype (HLA DR+, TAC+) = 15% and for natural killer (NK) cells (NKH1, Leu19+) = 17%. rIFN gamma appears as a well-tolerated and promising therapeutic agent with toxicities and mode of action probably distinct from IFN alpha and beta.
- Subjects :
- Adult
Male
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
Immunology
Gastroenterology
Interferon-gamma
Neoplasms
Internal medicine
Humans
Immunology and Allergy
Medicine
Interferon gamma
Dose-Response Relationship, Drug
business.industry
Liver Neoplasms
Recombinant Interferon Gamma
Immunotherapy
Middle Aged
medicine.disease
Recombinant Proteins
Dose–response relationship
Hypocholesterolemia
Cholesterol
Liver
Oncology
Creatinine
Injections, Intravenous
Toxicity
Vomiting
Drug Evaluation
Female
Chills
medicine.symptom
business
medicine.drug
Subjects
Details
- ISSN :
- 14320851 and 03407004
- Volume :
- 32
- Database :
- OpenAIRE
- Journal :
- Cancer Immunology, Immunotherapy
- Accession number :
- edsair.doi.dedup.....5a4a9fa413f4316c6453a1b28553ae24