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Clinical Trials |
Departments of Surgery [A. E. C., J. R. W., J. D. G., J. J. M.], Internal Medicine [B. G. R., J. J. M.], and Biostatistics [T. M. B.], University of Michigan, Ann Arbor, Michigan 48109-0932; Department of Medicine, Stanford University, Stanford, California 94305 [P. P. L.]; and Department of Pathology, Loyola University, Maywood, Illinois 60153 [B. J. N.]
Purpose: The objectives of this study were to assess the toxicity and immunologicalresponse induced by the intradermal (i.d) administration of tumor lysate-pulsed dendritic cells (DCs).
Experimental Design: Patients with stage IV solid malignancies were treated in cohorts that received 106, 107, and 108 DCs i.d. every 2 weeks for three vaccines. Each vaccine was composed of a mixture of half DCs pulsed with autologous tumor lysate and the other half with keyhole limpet hemocyanin (KLH). Peripheral blood mononuclear cells (PBMCs) harvested 1 month after the last immunization was compared with pretreatment PBMCs for immunological response. Delayed-type hypersensitivity reactivity to tumor antigen and KLH was also assessed.
Results: Fourteen patients received all three vaccines and were evaluable for toxicity and/or immunological monitoring. There were no grade 3 or 4 toxicities associated with the vaccines or major evidence of autoimmunity. Local accumulation of CD4+ and CD8+ T cells were found at the vaccination sites. There was a significant proliferative response of PBMCs to KLH induced by the vaccine. In 5 of 6 patients, the vaccine resulted in increased IFN-
production by PBMCs to KLH in an ELISPOT assay. Using the same assay, 3 of 7 patients’ PBMCs displayed increased IFN- production in response to autologous tumor lysate. One patient with melanoma also was observed to have an increased frequency of MART-1- and gp100-reactive CD8+ T cells after vaccination. By delayed-type hypersensitivity testing, 8 of 9 and 4 of 10 patients demonstrated reactivity to KLH and autologous tumor, respectively. Two patients with melanoma experienced a partial and a minor response, respectively.
Conclusion: The administration of tumor lysate-pulsed DCs is nontoxic and capable of inducing immunological response to tumor antigen. Additional studies are necessary to improve tumor rejection responses.
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