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Recombinant Human Tumor Necrosis Factor Administered as a 24-Hour Intravenous Infusion. A Phase I and Pharmacologic Study
Abstract
Recombinant human tumor necrosis factor (rH-TNF) is a cytokine with direct antitumor properties. In a phase I trial we continuously infused rH-TNF for 24 hours. We gave a total of 115 courses of therapy to 50 patients. Doses ranged from 4.5 to 645 micrograms of rH-TNF/m2. Systemic toxicity, including fever, chills, fatigue, and hypotension, increased with the dose of rH-TNF administered. Doses greater than 454 micrograms/m2 frequently caused severe lethargy and fatigue, which precluded hospital discharge of the patient at the completion of therapy. The dose-limiting toxicity was hypotension, and five patients treated at the two highest dose levels required dopamine treatment. Other organ-specific toxicity was modest and spontaneously resolved after 48 hours. The 24-hour infusions of rH-TNF were associated with significant decreases in serum cholesterol and high-density lipoprotein levels. Pharmacokinetic studies using an enzyme-linked immunosorbent assay demonstrated peak plasma rH-TNF levels of 90-900 pg/mL. Despite continuous infusion of rH-TNF, no steady-state level was achieved. The recommended phase II dose for rH-TNF as a 24-hour continuous infusion is 545 micrograms/m2.
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Cited by
Khovidhunkit, W., Kim, M.-S., Memon, R. A., Shigenaga, J. K., Moser, A. H., Feingold, K. R., & Grunfeld, C. (2004) · Journal of Lipid Research · doi:10.1194/jlr.r300019-jlr200 · Cited by 1,481
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Smith, R. S. (1991) · Medical Hypotheses · doi:10.1016/0306-9877(91)90272-z · Cited by 931
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Yirmiya, R. (1996) · Brain Research · doi:10.1016/0006-8993(95)01415-2 · Cited by 604
Eggermont, A. M., Schraffordt Koops, H., Liénard, D., Kroon, B. B., van Geel, A. N., Hoekstra, H. J., & Lejeune, F. J. (1996) · Journal of Clinical Oncology · doi:10.1200/jco.1996.14.10.2653 · Cited by 398
Haack, M., Hinze-Selch, D., Fenzel, T., Kraus, T., Kühn, M., Schuld, A., & Pollmächer, T. (1999) · Journal of Psychiatric Research · doi:10.1016/s0022-3956(99)00021-7 · Cited by 329
Metadata
- Authors
- Spriggs, D. R., Sherman, M. L., Michie, H., Arthur, K. A., Imamura, K., Wilmore, D., Frei, E., & Kufe, D. W.
- Venue
- JNCI Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 1988-09-07
- Volume
- 80
- Issue
- 13
- Pages
- 1039-1044
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2076970414
- Cited by
- 308
- References
- 0
- FWCI
- 12.07
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Recombinant Human Tumor Necrosis Factor Administered as a 24-Hour Intravenous Infusion. A Phase I and Pharmacologic Study. https://app.cochat.ai/papers/10.1093/jnci/80.13.1039
- The paper
- Spriggs, D. R., Sherman, M. L., Michie, H., Arthur, K. A., Imamura, K., Wilmore, D., Frei, E., & Kufe, D. W. (1988). Recombinant Human Tumor Necrosis Factor Administered as a 24-Hour Intravenous Infusion. A Phase I and Pharmacologic Study. JNCI Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/80.13.1039
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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