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Phase I trial of interleukin-2 plus gamma-interferon
K A Margolin1, J H Doroshow, S A Akman
1Department of Medical Oncology, City of Hope National Medical Center, Duarte, CA 91010-0269.
Journal of Immunotherapy : Official Journal of the Society for Biological Therapy
|January 1, 1992
Summary
This study found that combining Interleukin-2 (IL-2) with gamma interferon (gamma-IFN) is safe for cancer treatment. Recommended doses for outpatient therapy showed no significant organ toxicity.
Area of Science:
- Immunology
- Oncology
- Clinical Pharmacology
Background:
- Interleukin-2 (IL-2) and gamma interferon (gamma-IFN) show potential synergistic effects in enhancing cell-mediated antitumor cytotoxicity.
- Understanding the combined toxicity profile is crucial for effective cancer immunotherapy.
Purpose of the Study:
- To determine the dose-limiting toxicities of combined intravenous IL-2 and intramuscular gamma-IFN.
- To establish a maximum tolerated dose (MTD) for this combination therapy.
- To evaluate preliminary efficacy in patients with advanced cancers.
Main Methods:
- A Phase I clinical trial was conducted involving 25 patients.
- Patients received escalating doses of IL-2 and gamma-IFN on a thrice-weekly schedule (4 weeks on, 2 weeks off).
- Dose ranges: gamma-IFN 0.05-0.25 mg/m², IL-2 0.33-2.33 mg/m².
Main Results:
- Two partial responses were observed in patients with melanoma and lung adenocarcinoma, lasting over 11 and 8 months, respectively.
- Toxicities were consistent with those expected from individual agents, with no unusual or irreversible organ toxicities.
- No treatment-related deaths occurred during the trial.
Conclusions:
- The combination of IL-2 and gamma-IFN is well-tolerated at the tested doses.
- Recommended outpatient doses are IL-2 at 2.0 mg/m² and gamma-IFN at 0.25 mg/m², showing no significant organ toxicity.
- This combination warrants further investigation in Phase II trials for cancer immunotherapy.