TABLE 1.
Patient characteristics
| Characteristic | Dose (mg/kg) cohort
|
Total | |||||
|---|---|---|---|---|---|---|---|
| 0.5 | 1.0 | 1.5 | 2.0 | 3.0 | 4.0 | ||
| Groupa | |||||||
| 2 to 12 years | 8 | 10 | 9 | 12 | 10 | 8 | 57 |
| 13 to 17 years | 8 | 8 | 4 | * | * | * | 20 |
| All enrolled patients | 16 | 18 | 13 | 12 | 10 | 8 | 77 |
| Gender, age, and wt | |||||||
| No. male (%) | 10 (63) | 12 (67) | 7 (54) | 6 (50) | 5 (50) | 4 (50) | 44 (57) |
| No. white (%) | 12 (75) | 11 (61) | 9 (69) | 10 (83) | 10 (100) | 6 (75) | 58 (75) |
| Mean age (yr) ±SD | 9.9 ± 5.54 | 10.5 ± 4.97 | 9.2 ± 4.80 | 7.9 ± 2.71 | 7.8 ± 3.36 | 6.4 ± 2.77 | 9.0 ± 4.49 |
| Mean wt (kg) ±SD | 38.6 ± 19.59 | 45.9 ± 32.91 | 36.7 ± 18.33 | 29.5 ± 11.98 | 30.9 ± 13.18 | 28.0 ± 11.61 | 36.5 ± 21.59 |
| No. of patients (%) with underlying neoplastic diseasesb | |||||||
| ALL | 4 (25) | 6 (33) | 5 (39) | 4 (33) | 4 (40) | 2 (25) | 25 (33) |
| Solid tumor | 5 (31) | 6 (33) | 2 (15) | 5 (42) | 2 (20) | 2 (25) | 22 (29) |
| AML | 3 (19) | 4 (22) | 0 (0) | 1 (8) | 3 (30) | 0 (0) | 11 (14) |
| NHL | 2 (13) | 0 (0) | 0 (0) | 2 (17) | 1 (10) | 3 (38) | 8 (10) |
| Other | 2 (13) | 2 (11) | 6 (46) | 0 (0) | 0 (0) | 1 (13) | 11 (14) |
a
Due to slower-than-expected enrollment in the 13- to 17-year age group, entry of patients in this age group was terminated after full patient accrual in the 4.0-mg/kg per day dosage level of the 2- to 12-year age group (indicated by asterisks).
b
ALL, acute lymphocytic leukemia; AML, acute myelogenous leukemia; NHL, non-Hodgkin's lymphoma.