Abstract
Background: Evidence exists that the toxic effects of a-interferon can be ameliorated by co-administration of dexamethasone without compromise of therapeutic efficacy. We therefore conducted a phase I trial to determine the maximum tolerated dose of intermittent interferon when combined with oral dexamethasone. Patients and methods: Thirty patients with metastatic renal cell carcinoma were enrolled. The starting dose of interferon was 20 million IU/m2/day given as a subcutaneous injection days 1 to 4 of each 14 day cycle. Dose levels were escalated at increments of 5 million IU/m2. Dexamethasone 4 mg was administered orally every 6 hours during administration of high-dose interferon. Low-dose maintenance interferon, 3 million lU/m2/day, was administered without dose escalation on days 5 to 14 of each cycle. Results: The maximum tolerated dose of intermittent high-dose interferon was 40 million IU/m2/day. The dose limiting toxicity was fatigue. EEG abnormalities developed in five patients and neuropsychiatric parameters deteriorated significantly in seventeen. Conclusions: We conclude that co-administration of dexamethasone improves the tolerance of intermittent high-dose interferon. The results of this trial may be useful in designing high-dose interferon regimens for renal cell carcinoma and other interferon-sensitive diseases.
Original language | English |
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Pages (from-to) | 911-914 |
Number of pages | 4 |
Journal | Annals of Oncology |
Volume | 6 |
Issue number | 9 |
DOIs | |
State | Published - Nov 1995 |
Externally published | Yes |
Keywords
- Dexamethasone
- Renal cell carcinoma
- α-interferon