Table 2.
Principal toxicities observed on IL-12
| Toxicity, grade | 100 ng/kg IL-12 | 300 ng/kg IL-12 | 500 ng/kg IL-12 | 625 ng/kg IL-12 |
|---|---|---|---|---|
| Laboratory toxicities | ||||
| Anemia without hemolysis | ||||
| Grade 3 | 0 | 1 | 0 | 0 |
| Anemia with hemolysis | ||||
| Grade 2 | 0 | 1 | 1 | 0 |
| Grade 3 | 0 | 0 | 1 | 0 |
| Grade 4 | 0 | 0 | 1 | 0 |
| Neutropenia | ||||
| Grade 3 | 1 | 2 | 6 | 2 |
| Grade 4 | 1 | 4 | 7 | 1 |
| Elevated bilirubin | ||||
| Grade 3 | 0 | 2 | 4 | 1 |
| Grade 4 | 0 | 0 | 1 | 0 |
| Elevated transaminase | ||||
| Grade 3 | 0 | 5 | 2 | 2 |
| Elevated amylase | ||||
| Grade 3 | 0 | 1 | 0 | 0 |
| Clinical toxicities | ||||
| Constitutional† | ||||
| Grade 2 | 2 | 3 | 10 | 2 |
| Grade 3 | 0 | 0 | 1 | 1 |
| Arthralgia | ||||
| Grade 2 | 0 | 0 | 3 | 2 |
| Depression | ||||
| Grade 1 | 0 | 0 | 3 | 1 |
| Grade 2 | 0 | 2 | 2 | 1 |
| Grade 5 | 0 | 1 | 0 | 0 |
| Headache | ||||
| Grade 2 | 0 | 2 | 4 | 2 |
| Grade 3 | 0 | 0 | 1 | 0 |
| Nausea | ||||
| Grade 2 | 0 | 0 | 2 | 2 |
| Vomiting | ||||
| Grade 2 | 0 | 0 | 2 | 1 |
| Skin rash | ||||
| Grade 3 | 0 | 0 | 0 | 1 |
| Weight loss | ||||
| Grade 3 | 0 | 1 | 0 | 0 |
Shown here are the principal toxicities and the grades observed in patients receiving IL-12 that were not primarily attributed to another cause. All patients were assessable for toxicity. For patients receiving 100 ng/kg, n = 5; 300 ng/kg, n = 8; 500 ng/kg, n = 17; and 625 ng/kg, n = 4. Shown are all toxicities of grade 3 and above. In addition, anemia with hemolysis and other noteworthy toxicities of grade 2 are shown, as well as any grade of depression. In addition to these toxicities, (1) 1 patient on the 100-ng/kg dose had grade 3 anemia attributable to zidovudine; (2) 3 patients had elevated bilirubin levels (1 grade 3 and 2 grade 4) attributable to indinavir administration (and in one case also to sepsis); (3) 1 patient on the 300-ng/kg dose died of sepsis arising in a site of KS 1 week after stopping dosing, and 1 patient on the 500-ng/kg dose died of complications from concurrent multicentric Castleman disease and antithrombotic therapy administered for a possible pulmonary embolism. In addition, one patient on the 500-ng/kg dose developed a grade 4 elevated bilirubin and transaminases, which on investigation were found to be attributable to his taking at least twice the prescribed dose.
*In addition to the anemia with hemolysis toxicities noted, one patient on the 500-ng/kg dose and one patient on the 625-ng/kg dose was found to have increased hemolysis without anemia.
Constitutional symptoms observed were fevers, myalgias, and fatigue.