A randomized phase I/II study of continuous versus intermittent intravenous interferon gamma in patients with metastatic melanoma
| Autor: | C. A. Davis, John M. Kirkwood, J Balser, S D Reich, T. Trautman, P Witman, S. A. Rudnick, Marc S. Ernstoff |
|---|---|
| Rok vydání: | 1987 |
| Předmět: |
Adult
Male Cancer Research Time Factors Dose Constitutional symptoms Neutropenia Interferon-gamma Random Allocation Pharmacokinetics Humans Medicine Infusions Parenteral Interferon gamma Melanoma Aged business.industry Incidence (epidemiology) Middle Aged medicine.disease Oncology Anesthesia Toxicity Drug Evaluation Female Chills medicine.symptom business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 5:1804-1810 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.1987.5.11.1804 |
| Popis: | Thirty patients with documented metastatic melanoma were randomly assigned to receive recombinant DNA-produced gamma-interferon (specific activity approximately, 20 MU/mg) intravenously (IV) over either two or 24 hours at dosages of 3, 30, 300, 1,000, or 3,000 micrograms/m2. Objective toxicity resembled that of alpha-interferon and included fever, chills, myalgias, headache, and fatigue. Neutropenia, elevations in liver enzymes, tachyarrhythmias, and CNS changes also were noted. Dose-limiting toxicity included neutropenia, liver enzyme abnormality, constitutional symptoms, and a change in mental status. The incidence of toxicity was qualitatively similar in both two- and 24-hour treatment arms, but was quantitatively more severe in the 24-hour continuous infusion arm. Maximum tolerated dose was 1,000 micrograms/m2 in both schedules. Pharmacokinetic studies showed a half-life of six to nine hours. One patient had a complete response after two cycles of therapy and an additional patient entered partial remission after three cycles. Recombinant gamma-interferon (rIRN-gamma) is tolerated at dosages of 1,000 micrograms/m2 administered daily either by two or 24 hour infusion for 14 days in patients with metastatic melanoma. The responses documented in this early trial warrant further evaluation for the treatment of metastatic melanoma. |
| Databáze: | OpenAIRE |
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