A phase I study of subcutaneous recombinant interleukin-2 and interferon alfa-2a

✍ Scribed by Mark J. Ratain; Edwin R. Priest; Linda Janisch; Nicholas J. Vogelzang

• Publisher: John Wiley and Sons
• Year: 1993
• Tongue: English
• Weight: 495 KB
• Volume: 71
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(19930401)71:7<2371::aid-cncr2820710731>3.0.co;2-1

✦ Synopsis

Background. Both recombinant in1 erferon alfa and interleukin-2 (IL-2) have been shown to lave some activity as single agents in metastatic renal cj !I1 cancer (RCC), although their activity is minimal in mo -e common solid tumors. Recent preclinical studies hav ? suggested that the combination of these two agents is I !specially promising.

Methods. Subcutaneous recombii kant interferon alfa-2a and 1L-2 were administered at one of five dose levels to 33 patients with refractory solic. tumors, including 21 patients with RCC. A constant ratio of 5:l of interferon alfa-2a to IL-2 was used. Interferon alfa-2a and IL-2 were administered three and five times weekly, respectively, for a total of 4 weeks, followed by a rest of 1-3 weeks between cycles.

The dose-limiting toxic effects included hypotension, nephrotoxicity, and fatigue. At the recommended Phase I1 dose of 7.5 million units (MU)/m2 of interferon alfa-2a and 1.5 MU/m2 of IL-2,12 patients were treated. Ten of 12 completed the 4-week cycle without modification. Four patients at that dose level had Grade 3-4 toxic effects. Partial responses were observed in 4 of 16 assessable patients with RCC.

Conclusions. Subcutaneous interferon alfa-2a and IL-2 can be self-administered safely on an outpatient basis. At tolerable doses, responses can be achieved in