The effect of leukocyte interleukin injection (Multikine) treatment on the peritumoral and intratumoral subpopulation of mononuclear cells and on tumor epithelia: a possible new approach to augmenting sensitivity to radiation therapy and chemotherapy in oral cancer--a multicenter phase I/II clinical Trial.

What Was Tested

The paper reports a study of Adjuvants, Immunologic, published as a phase 2 clinical trial.

The main objective of this study was to investigate the effect of the administration of a novel immunoadjuvant, leukocyte interleukin injection, as part of an immuno-augmenting treatment regimen on the peritumoral and intratumoral subpopulations of the tumor infiltrating mononuclear cells and on the epithelial and stromal components, when administered to patients with advanced primary oral squamous cell carcinoma classified as T2-3N0-2M0, as compared with disease-matched control patients (not treated with leukocyte interleukin injection).

Trichrome staining was used to evaluate connective tissue, and morphometric measurements were made using ImagePro analysis software.

Who Took Part

PubMed indexes the participants as adults, middle-aged adults and older adults, both men and women.

Paraffin-embedded tumor samples obtained at surgical resection of the residual tumor (between days 21 and 28 after treatment initiation) were used.

How the Study Was Run

The researchers set it up as a multicenter study.

More than one site took part, so the participants came from several places.

Multicenter Phase I/II clinical trial.

Histological analysis, necrosis evaluation, and American Joint Committee on Cancer grading were performed from H&E-stained sections.

Immunohistochemical analysis was performed on three different tumor regions (surface, zone 1; center, zone 2; and tumor-stroma interface, zone 3).

Cell cycling was determined by the use of Ki-67 marker.

What Was Measured

Topics PubMed links to this paper include Adjuvants, Immunologic, Antineoplastic Agents, Alkylating, Antineoplastic Combined Chemotherapy Protocols, CD3 Complex, Carcinoma, Squamous Cell, Cyclophosphamide and Dendritic Cells.

What This Means in Plain Language

The paper is a multicenter study of Adjuvants, Immunologic.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2003 (The Laryngoscope), a journal based in United States.

More context: all human trials.