A clinical phase I/II trial of rhIL-4 applied topically in patients with oral squamous cell carcinomas to assess safety and therapeutic activity.
Oncol Rep
; 13(3): 449-52, 2005 Mar.
Article
em En
| MEDLINE
| ID: mdl-15706415
ABSTRACT
Besides its immunoregulatory effects, interleukin-4 (IL-4) has growth inhibitory activity on cells from human solid tumors, and IL-4 receptors are present on tumor cells including cells from head and neck squamous cell carcinomas. We have conducted a phase I/II trial in patients with oral squamous cell carcinomas of T(4), N(+) (1 exception) stage to assess safety and therapeutic activity of recombinant human (rh) IL-4 applying the drug intratumorally 3 times a week with dose escalation for a duration of 4 weeks. A total of 7 patients entered the study using doses of 1, 3, and 5 microg/kg. There was no reduction of tumor size with 1 patient showing clear progression of the tumor after 4 weeks of treatment. This, and the observation of limiting toxicity occurring as local pain at the injection site, led to study termination. Therefore, rhIL-4 cannot be recommended as an antitumor drug in this disease using monotherapy with the schedules applied in this trial.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Bucais
/
Carcinoma de Células Escamosas
/
Interleucina-4
/
Antineoplásicos
Tipo de estudo:
Etiology_studies
Limite:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Oncol Rep
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2005
Tipo de documento:
Article
País de afiliação:
Alemanha