Table II.
Dose Escalation History And DLTs During Course I
| Strata | Dose (mg/m2) | No. of Patients Entered | No. of Patients Evaluable | No. of DLTs | DLTs |
|---|---|---|---|---|---|
| I | 110 | 3 | 3 | 1 | Grade 3 SGOT(AST) |
| 110 | 4 | 3 | 0 | ||
| 145 | 3 | 3 | 1 | Grade 3 Hallucinations | |
| 145 | 3 | 2 | 1 | Grade 3 SGOT(AST) and SGPT(ALT) | |
| MTD Established at 110 mg/m2 | |||||
| 110 | 6 | 0 | 0 | Six additional patients were treated at the MTD to better describe toxicity | |
| Protocol modified to 1) investigate the relationship between the occurrence of hallucinations and SU5416 and 2) to eliminate transient liver transaminase levels as DLT – accrual re-opens at the 145 dose level | |||||
| 145 | 4 | 3 | 0 | ||
| Protocol closed to accrual due to drug availability | |||||
| II | 48 | 3 | 3 | 0 | |
| 65 | 3 | 2 | 1 | Grade 3 SGPT(ALT) | |
| Protocol modified to 1) investigate the relationship between the occurrence of hallucinations and SU5416 and 2) to eliminate transient liver transaminase levels as DLT – accrual of additional patients at the 65 dose level | |||||
| 65 | 4 | 3 | 1 | Grade 3 Headache | |
| Protocol closed to accrual due to drug availability | |||||