Table 5.
Phase II studies with DON.
| Number of patients | Tumor type | DON schedule | Observations | References |
|---|---|---|---|---|
| 22 | Advanced lung cancer | 160 mg/m2 days 1–3, every 21 days | 4 (18.1%) had transient disease stabilization (3–12 weeks) | [60] |
|
| ||||
| 30 | Advanced colorectal | 160 mg/m2 days 1–3, every 21 days | 16 (53%) had disease stabilization (3–26 weeks) | [61] |
|
| ||||
| 23 (14 evaluable) | Advanced colorectal | 300 mg/m2 days 1–5 every 2 weeks (deescalated to 200 mg) |
PR 1 (7%) SD 2 (14%), 2 and 5.5 months |
[62] |
|
| ||||
| 36 | Pretreated advanced sarcoma | 50 mg/m2 days 1–5, every 28 days | No responses median OS 4.8 months |
[63] |
|
| ||||
| 55 | Advanced, refractory malignancies | 140 mg/m2 twice weekly + PEG-PGA | Treatment delivered 1–379 days 1 PR and 1 SD (>12 months) in 17 colorectal pts. 5 of 6 with lung cancer SD in the first 3 months of inclusion |
[64] |
PEG-PGA: PEGylated recombinant human glutaminase; PR: partial response; CR: complete response; SD: stable disease; OS: overall survival.