A PHASE I TRIAL OF BUCCAL ADMINISTRATION OF LOW-DOSE RECOMBINANT ALFA INTERFERON (ROFERON-A) (MEETING ABSTRACT)

Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.

A PHASE I TRIAL OF BUCCAL ADMINISTRATION OF LOW-DOSE RECOMBINANT ALFA INTERFERON (ROFERON-A) (MEETING ABSTRACT)

Proc Annu Meet Am Soc Clin Oncol; 10:A722 1991. Unique Identifier : AIDSLINE ICDB/91672104
Dhingra K; Dimery I; Mclaughlin P; Rothberg JM; Gutterman JU; M.D. Anderson Cancer Center, Houston, TX 77030

Abstract: Based on the recent data suggesting potential immunomodulatory effects of low doses of alpha interferon (IFN) given in the oral cavity in patients (pts) with AIDS and in animals, we treated 21 pts with advanced malignancies in a Phase I study of low-dose IFN to evaluate its biological effects. The dose levels (1-5) were 1, 2, 4, 8, and 16 U/kg/day, respectively. IFN was swished orally once a day for 8 wk. The diagnoses included nodular lymphoma/CLL (4), melanoma (3), head and neck (3), genitourinary (4), lung/pleura (3) and other (4) malignancies. Mild nausea (1 pt) was the only toxicity observed. No consistent changes in quantitative Ig, lymphocyte subsets, beta-2 microglobulin were observed. T4/T8 ratio was inverted (less than 1) in 5 pts prior to study and remained so during treatment. In 7 pts with low T4/T8 ratio (median 1.1, range 1.02-1.6) prestudy, the ratio became inverted during treatment. A greater than 4x increase in NK cells was seen in a pt with mesothelioma. Increase in appetite, energy level, and general well-being was reported by 6 pts (3/4, 2/4, 1/3 at levels 1, 2 and 5, respectively). Of 17 pts evaluable for response, 2 had stable disease (including the pt with marked increase in NK cells) and 15 had progressive disease. Whether the subjective improvement reported by some of our pts is related to IFN or placebo effect remains to be determined.

Keywords: Administration, Buccal Dose-Response Relationship, Drug Drug Evaluation Human Interferon Alfa, Recombinant/ADMINISTRATION & DOSAGE/*TOXICITY/ THERAPEUTIC USE Neoplasms/*THERAPY CLINICAL TRIAL ABSTRACT
911030
M91A1125

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