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Phase II study of low dose cyclophosphamide and intravenous interleukin-2 in metastatic renal cancer

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Abstract

Thirteen patients with metastatic renal cancer were treated in a phase II trial with interleukin-2, 21.6 million IU/m2 intravenously daily for five days on two consecutive weeks, starting 3 days after the administration of low dose cyclophosphamide 350 mg/m2 intravenously. Treatment cycles were repeated every 21 days. No responses were seen (95% Confidence Interval: 0–22%). The most common toxicities were fever, fatigue, hypotension, nausea/emesis, and myalgia/arthralgia. There were 11 episodes of Grade III toxicity including Grade III hypotension in 7 patients. Because of the significant toxicity and the lack of observed response, the study was discontinued. Cyclophosphamide and interleukin-2 at the dose and schedule used in this study has considerable toxicity and is unlikely to improve on response rates previously seen with other IL-2-based regimens in metastatic renal cancer.

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Authors and Affiliations

  1. Kenneth Norris Jr Cancer Center, 90033, Los Angeles, CA, USA

    Walter D. Y. Quan Jr, Grace E. Dean, Gary Lieskovsky, Malcolm S. Mitchell & Raymond A. Kempf

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  1. Walter D. Y. Quan Jr
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  2. Grace E. Dean
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  3. Gary Lieskovsky
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  4. Malcolm S. Mitchell
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  5. Raymond A. Kempf
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Quan, W.D.Y., Dean, G.E., Lieskovsky, G. et al. Phase II study of low dose cyclophosphamide and intravenous interleukin-2 in metastatic renal cancer. Invest New Drugs 12, 35–39 (1994). https://doi.org/10.1007/BF00873233

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