A phase I/II trial of adoptive immunotherapy using autologous activated macrophages (AAM) in patients (pts) with advanced colorectal cancer (CRC) (Meeting abstract).

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

A phase I/II trial of adoptive immunotherapy using autologous activated macrophages (AAM) in patients (pts) with advanced colorectal cancer (CRC) (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 14:A577 1995. Unique Identifier : AIDSLINE ICDB/95613730
Eymard JC; Lopez M; Bernard J; Adjizian JC; Di Borgo CP; Cattan A; Institut Jean Godinot, Reims, France

Abstract: Background and purpose: AAM have been shown to kill malignant cells in vitro and to migrate into the tumor in animal models (Fidler, Bartholeyns) and human beings (Stevenson, Faradji). A trial was undertaken in pts in order to evaluate AAM clinical tolerance, efficacy and biological effects. Pts and methods: For ethical reasons, pts with inoperable advanced chemoresistant CRC in progression were treated. Eligibility criteria included measurable disease; age less than 75 yr; PS less than or equal to 2; normal bone marrow and hepatic, renal, cardiac functions; negative HBS antigen and HIV serology; no corticosteroid treatment and signed informed consent. Mononuclear cells were collected by 6 leukapheresis, one per wk, and cultured for 7 days, enabling the differentiation of monocytes to macrophages. Activation was generated by adding interferon-gamma on the last day, then purification of AAM was performed by elutriation: in the resulting suspension 85% of cells were AAM. The schedule adopted, ie leukapheresis in the morning, and after a 3-4 hr rest, iv infusion of cells harvested the wk before, allowed ambulatory treatment. Results: 11 pts were treated: 7 men/4 women; median age 61 yr (49-70); PS 1/2 = 6/5; primary tumor: colon/rectum= 9/2; metastases: liver-9 pts, lung-6 pts, abdomen-pelvis-2 pts. Each pt received on average a total of 7.9 x 10(9) AAM (4.3-16.7x10(9)). Tolerance: fever (WHO grade 2) during the hrs following infusion in 6/11 pts, but no other significant toxicity and no modification of usual blood parameters. Tumor response: no change-2 pts for 10 and 8 wk, respectively, from the start of immunotherapy; progressive disease-9 pts. Conclusions: Clinical tolerance was excellent. No anticancer activity was observed in our pts but they were bearing very bulky tumors. New trials are planned in pts with small tumor burden and optimization of AAM preparation is under way.

Keywords: Adult Aged *Cell Transplantation/ADVERSE EFFECTS Colorectal Neoplasms/*THERAPY Female Human *Immunotherapy, Adoptive/ADVERSE EFFECTS Leukapheresis Macrophages/CYTOLOGY/*TRANSPLANTATION Male Middle Age Transplantation, Autologous ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II
951230
M95C3229

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