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A phase I study of recombinant interleukin 2 plus recombinant beta-interferon
R L Krigel1, K A Padavic-Shaller, A R Rudolph
1Department of Medicine, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111.
Cancer Research
|July 1, 1988
Summary
This Phase I trial combined Interleukin 2 (IL-2) and Interferon beta (IFN-beta) for cancer treatment. The combination therapy proved tolerable and biologically active, showing potential for antitumor responses.
Area of Science:
- Oncology
- Immunotherapy
Background:
- Interleukin 2 (IL-2) exhibits antitumor properties.
- Beta-interferon (IFN-beta) enhances IL-2's in vitro antitumor activity.
Purpose of the Study:
- To evaluate the safety and biological activity of a combination therapy using IL-2 and IFN-beta.
- To determine the maximum tolerated doses (MTD) for the combined intravenous (i.v.) administration.
Main Methods:
- A Phase I clinical trial involving 47 patients treated with escalating doses of IL-2 and IFN-beta administered intravenously three times weekly.
- Route of administration for IL-2 was switched from subcutaneous (s.c.) to i.v. due to antibody development.
Main Results:
- Maximum tolerated doses were established at 5 x 10^6 units/m2 of IL-2 and 10 x 10^6 units/m2 of IFN-beta.
- Dose-limiting toxicities included fatigue, anorexia, depression, and arthralgias.
- Twenty-two percent of patients showed significant lymphokine-activated killer (LAK) cell activity, associated with antitumor responses.
Conclusions:
- Intermittent i.v. bolus IL-2 and IFN-beta therapy is tolerable and biologically active.
- LAK cell activity generated by this therapy may correlate with antitumor responses.
- Recommended Phase II dose: 5 x 10^6 units/m2 IL-2 plus 6 x 10^6 units/m2 IFN-beta.