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. Author manuscript; available in PMC: 2016 Mar 5.
Published in final edited form as: J Neurooncol. 2008 Sep 17;91(2):175–182. doi: 10.1007/s11060-008-9693-3

Table 1.

Radiological Criteria for Unacceptable Progression:

Transient enlargement of enhancing disease with subsequent shrinkage has been reported during poly-ICLC treatment. Because of this, if the patient has progressive disease by the conventional definition (≥ 25% increase in the sum of products of all measurable lesions over the smallest sum observed using the same techniques as baseline or appearance of any new lesion/site) but does not have unacceptable progression by the definitions below, the treating physician and patient have the options of continuing poly-ICLC treatment on this protocol or of discontinuing treatment:

  1. ≥50% increase in bi-dimensional diameters for tumors starting with bi-dimensional diameters > 4 cm2.

  2. ≥100% increase in bi-dimensional diameters for tumors starting with bi-dimensional diameters of 1.0 to 4.0 cm2.

  3. Bi-dimensional diameters ≥ 2.0 cm2 for tumors starting with no measurable disease or for bi-dimensional diameters ≤1.0 cm2.

  4. Unacceptable worsening of neurological symptoms that cannot be controlled with corticosteroids

  5. Any other radiological or clinical evidence of worsening to the extent that the treating physician feels it is not in the patient’s best interest to continue poly-ICLC