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Phase iii randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma

✍ Scribed by Teresa Murray Law; Robert J. Motzer; Madhu Mazumdar; Kenneth W. Sell; Philip Walther; Michael O'Connell; Amanullah Khan; Vaia Vlamis; Nicholas J. Vogelzang; Dean F. Bajorin

Publisher
John Wiley and Sons
Year
1995
Tongue
English
Weight
723 KB
Volume
76
Category
Article
ISSN
0008-543X

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✦ Synopsis

Background. Treatment with interleukin-2 (IL-2) and lymphokine-activated killer cells (LAK) resulted in responses in some patients with advanced renal cell carcinoma (RCC). However, the relative therapeutic benefit of the addition of LAK to IL-2 was unknown.

Methods. A randomized Phase I11 trial was conducted in patients with RCC comparing continuous intravenous infusion (CI) IL-2 alone with CI IL-2 plus LAK. Interleukin-2 was administered at 3 X 10" U/mz/day on days 1-5, 13-17, 21-24, and 28-31. Patients on the LAK treatment arm underwent leukapheresis on days 8-10 and LAK cell reinfusion on days 13-15. The results are reported with long-term follow-up. The published experience with IL-2 alone or with the addition of LAK was investigated in a quantitative literature survey. The response proportions were studied by schedule (high dose bolus, moderate dose, low dose) and by concomitant administration of LAK.

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