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Contribution to Book
Monitoring Combination Therapy Trials: New Challenges for the Clinical Laboratory
Combination Therapies 2 (1993)
  • Jeffrey L. Rossio, National Institutes of Health
  • Helen C. Rager, National Institutes of Health
  • Carol S. Goundry
  • Walter J. Urba, National Institutes of Health
Cytokines are, with few exceptions, normally undetectable in serum. This is primarily due to their role as local mediators of immunological signals among cells participating in immune or inflammatory reactions. However, therapeutic administration of cytokines often results in measurable serum cytokine levels which may be clinically informative. In addition, clinical and animal model data show that injection of one cytokine often leads to the induction of appearance of significant amounts of other cytokines. For example, the administration of IL-1 leads to measurable serum IL-6 and G-CSF; IL-2 administration induces interferon-gamma production. Clinical side effects may be due to the presence of such induced cytokine(s); these side effects may or may not be related to the intended therapeutic role(s) of the agents. Thus, knowledge of the spectrum of cytokines present may guide clinical cytokine use (Oppenheim, et al., 1992; Rossio et al., 1992). It is now possible to measure a large number of cytokines by immunoassay (ELISA or RIA) to a sensitivity of 50 picograms/ml or less. Levels of some cytokine receptors (e.g., IL-2, TNF) can also be measured in serum and other body fluids. The decisions as to which cytokines or receptors to monitor during clinical trials, and when to look for them, depends partly on empirical observations, and partly on an understanding of the immunological interactions involved (Clemens, et al., 1987; Coligan, et al., 1991; Dawson, 1991). The addition of secondary therapeutic agents, which may be immunosuppressive or stimulatory, further complicates the picture.
  • Granulocyte Colony Stimulate Factor,
  • Cytokine Assay,
  • Biological Response Modifier,
  • Therapeutic Administration,
  • Clinical Side Effect
Publication Date
Enrico Garaci, Allan L. Goldstein
Citation Information
Jeffrey L. Rossio, Helen C. Rager, Carol S. Goundry and Walter J. Urba. "Monitoring Combination Therapy Trials: New Challenges for the Clinical Laboratory" Boston, MACombination Therapies 2 (1993) p. 11 - 21
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