Background: We studied the clinical efficacy and toxicity of a low-dose interferon-7 (IFN-7) regimen in patients with metastatic renal cell carcinoma (RCC). Methods: Eighteen unselected patients with metastatic RCC (median Karnofsky 80%; median sites of metastases = 2; 10 patients were pretreated with immuno-therapy) were included in this protocol. They were treated with IFN-7 at 150 μg s.c. once a week until tumor progression. Each treatment cycle consisted of 6 weeks of therapy on an outpatient basis followed by a pause of 2 weeks. Results: Toxicity was generally mild with low-grade fever predominating. Of 17 patients evaluable for response, one partial remission (5 months) was observed in a patient with pulmonary and mediastinal metastases and 4 further patients had stable disease (5, 7, 7 and 12 months). Four patients received IFN-α/IL-2 subsequent to treatment with IFN-7. Interestingly the patient who achieved a partial remission had a further partial response to IFN-α and IL-2 following relapse under therapy with IFN-7. Conclusion: Treatment with low-dose IFN-7 had limited clinical efficacy in our unselected patient group.

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