Combined Levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma a phase II study

Edward T. Creagan; Robert D. Hestorff; Vera J. Suman; James A. Mailliard; Suresh Nair; James E. Krook; John W. Kugler; Robert F. Marschke; John C. Michalak; Loren K. Tschetter

doi:10.1097/00000421-199804000-00008

Combined Levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma a phase II study

Edward T. Creagan, Robert D. Hestorff, Vera J. Suman, James A. Mailliard, Suresh Nair, James E. Krook, John W. Kugler, Robert F. Marschke, John C. Michalak, Loren K. Tschetter

Quantitative Health Sciences

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Abstract

Adoptive immunotherapy (AI) with interleukin-2 (IL-2) and lymphokine- activated killer (LAK) cells is an antineoplastic modality in which immune- activated cells are administered to a host having cancer in an attempt to mediate tumor regression. Levamisole (LEV), an immune stimulant, has been suggested as having therapeutic effectiveness in a variety of cancers. After a phase I trial of recombinant IL-2 plus LEV, a phase II trial of this combination was conducted in patients who had advanced renal cell carcinoma. The regimen was IL-2 at 3 x 10⁶ U/m² daily x 5 plus LEV at 50 mg/m² perorally three times a day x 5. Only one of the 22 eligible patients had a regression. It was a partial regression, 85 days in duration. The median time to treatment failure (refusal, progression, or off study because of toxicity) was 36 days. The only grade 4 toxicity reported was lethargy. This regimen is not recommended for further testing in patients who have advanced renal cell carcinoma.

Original language	English (US)
Pages (from-to)	139-141
Number of pages	3
Journal	American Journal of Clinical Oncology: Cancer Clinical Trials
Volume	21
Issue number	2
DOIs	https://doi.org/10.1097/00000421-199804000-00008
State	Published - Apr 1998

Keywords

Interleukin-2
Renal cell cancer

ASJC Scopus subject areas

Oncology
Cancer Research

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Creagan, E. T., Hestorff, R. D., Suman, V. J., Mailliard, J. A., Nair, S., Krook, J. E., Kugler, J. W., Marschke, R. F., Michalak, J. C., & Tschetter, L. K. (1998). Combined Levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma a phase II study. American Journal of Clinical Oncology: Cancer Clinical Trials, 21(2), 139-141. https://doi.org/10.1097/00000421-199804000-00008

Creagan, ET, Hestorff, RD, Suman, VJ, Mailliard, JA, Nair, S, Krook, JE, Kugler, JW, Marschke, RF, Michalak, JC & Tschetter, LK 1998, 'Combined Levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma a phase II study', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 21, no. 2, pp. 139-141. https://doi.org/10.1097/00000421-199804000-00008

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abstract = "Adoptive immunotherapy (AI) with interleukin-2 (IL-2) and lymphokine- activated killer (LAK) cells is an antineoplastic modality in which immune- activated cells are administered to a host having cancer in an attempt to mediate tumor regression. Levamisole (LEV), an immune stimulant, has been suggested as having therapeutic effectiveness in a variety of cancers. After a phase I trial of recombinant IL-2 plus LEV, a phase II trial of this combination was conducted in patients who had advanced renal cell carcinoma. The regimen was IL-2 at 3 x 106 U/m2 daily x 5 plus LEV at 50 mg/m2 perorally three times a day x 5. Only one of the 22 eligible patients had a regression. It was a partial regression, 85 days in duration. The median time to treatment failure (refusal, progression, or off study because of toxicity) was 36 days. The only grade 4 toxicity reported was lethargy. This regimen is not recommended for further testing in patients who have advanced renal cell carcinoma.",

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Combined Levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma a phase II study

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