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Phase I study of weekly high-dose human lymphoblastoid interferon
Cancer Treatment Reports
|September 1, 1984
Summary
High-dose weekly interferon infusions show anticancer activity in advanced cancers. The treatment was well-tolerated, with manageable side effects, and did not cause myelosuppression or hepatotoxicity.
Area of Science:
- Oncology
- Immunology
Background:
- Interferon exhibits antineoplastic properties.
- Optimal dosing for interferon therapy remains undefined.
Purpose of the Study:
- To determine the maximum tolerated dose (MTD) and toxicity profile of weekly high-dose human lymphoblastoid interferon in advanced cancer patients.
- To assess the antineoplastic activity of this treatment regimen.
Main Methods:
- Phase I clinical trial involving 12 patients with advanced cancer.
- Treatment administered as a 3-hour intravenous infusion weekly.
- Dose escalation to determine MTD and dose-limiting toxicities.
Main Results:
- The median MTD was 55 x 10^6 units/m^2.
- Dose-limiting toxicities included fever, fatigue, myalgias, anorexia, and weakness.
- No myelosuppression or hepatotoxicity was observed.
- One patient with metastatic melanoma achieved a durable complete remission (2 years).
- The treatment was well-tolerated up to 40-50 x 10^6 units/m^2.
Conclusions:
- Weekly high-dose intravenous interferon demonstrates antineoplastic activity in advanced cancers.
- The regimen is generally well-tolerated, with manageable side effects and no significant myelosuppression or hepatotoxicity.
- Recommended starting dose for future trials is 30 x 10^6 units/m^2, with weekly escalation based on patient tolerance.