Phase I study of ex vivo anti-CD3-stimulated CD4+ T cells, interleukin-2 (IL-2) and cyclophosphamide (CTX) (Meeting abstract).

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Phase I study of ex vivo anti-CD3-stimulated CD4+ T cells, interleukin-2 (IL-2) and cyclophosphamide (CTX) (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 15:A1044 1996. Unique Identifier : AIDSLINE ICDB/196636044
Curti B; Ochoa A; Kopp W; Gause B; Janik J; Fenton R; Miller L; Holmlund J; Creekmore S; Sznol M; Longo D; CRB, NCI, Frederick, MD 21701

Abstract: A prior CRB trial treated patients (pts) with anti-CD3-stimulated T cells, IL-2 and CTX. In vivo T-cell expansion was achieved, but responses were infrequent. Animal models showed that CD4+ T cells promoted greater antitumor effects than CD8+ or unselected T cells, and that CTX timing was important. Based on these findings, pts with advanced cancer were treated as follows: Day 0 pheresis to obtain 2.0 x l0(l0) mononuclear cells. In the first 6 pts, intravenous (iv) CTX (300 or 1000 mg/m2) was given after pheresis. All other pts received CTX (l000 mg/m2) on day 0 with pheresis 7-l0 days later, just before or after the white blood cell nadir. CD4+ T cells were obtained by negative selection with MicroCellector flasks (AIS, Inc, Menlo, CA) and incubated for 4 days with anti-CD3 (lO ng/ml) and IL-2 (30 u/ml). On day 5, CD4+ cells (range 2.0 x l0(9) to 9.7 x l0(9) cells) were given iv, and IL-2 (3 mu/m2/day x 7 days, Roche units) was begun by continuous iv infusion. Treatment was repeated on day 28. Results from flow cytometry of peripheral blood CD3-gated T cells (mean values on 16 pts) are shown in a table. Anti-CD3-stimulated CD4+ cells, CTX and IL-2 increase the percent of circulating activated CD4+ T cells and decrease CD8+ T cells, resulting in an increased CD4/CD8 ratio. Of 18 evaluable pts, two PRs (melanoma), three stable disease (renal carcinoma) and two mixed responses (melanoma and head and neck carcinoma) have been observed.

Keywords: Antigens, CD3/BLOOD Antigens, CD4/BLOOD CD4-CD8 Ratio Cyclophosphamide/*THERAPEUTIC USE Human Interleukin-2/*THERAPEUTIC USE Neoplasms/*DRUG THERAPY/IMMUNOLOGY T-Lymphocyte Subsets/DRUG EFFECTS ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE I
961230
M96C1579

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