Table 3.
Dose-limiting toxicities
Dose Level | No. Patients | Grade 3 or 4 Hematologic Toxicity | Grade 4 Nonhematologic Toxicity | Increased ICP | Decrease in GCS or New Focal Neurologic Deficit | Percent DLT |
---|---|---|---|---|---|---|
Residual tumor | ||||||
25 ng/ml | 3 | 0 | 0 | 0 | 0 | 0% |
50 ng/ml | 6 | 0 | 0 | 0 | 1a | 16.7% |
100 ng/ml | 6 | 0 | 1b | 0 | 0 | 16.7% |
No residual tumor | ||||||
25 ng/ml | 3 | 0 | 0 | 0 | 0 | 0% |
50 ng/ml | 2 | 0 | 0 | 0 | 0 | 0% |
100 ng/ml | 0 | 0 | 0 | 0 | 0 | 0% |
Abbreviations: ICP, intracranial pressure; GCS, Glasgow Coma Scale score; DLT, dose-limiting toxicity.
Hemiparesis that may have been related to recurrent tumor.
Constitutional.