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Phase 1 multicenter study of vincristine sulfate liposomes injection and dexamethasone in adults with relapsed or refractory acute lymphoblastic leukemia
Cancer, 08/31/09
Thomas DA et al. – Vincristine sulfate liposome injection (VSLI) + dexamethasone is an effective salvage therapy option for relapsed/refractory
Methods- Phase 1 trial
- VSLI iv at 1.5, 1.825, 2.0, 2.25, or 2.4 mg/m2 iv in a 3 + 3 dose escalation design; dexamethasone (40 mg) was given on d 1-4 and 3 11-14 of each 4 w cycle
- 36 adults with relapsed/refractory ALL, all previously treated with conventional VCR, received at least 1 dose of VSLI
- The MTD of VSLE was 2.25 mg/m2
- 1 patient had grade 3 motor neuropathy, grade 4 seizure, and grade 4 hepatotoxicity at 2.4 mg/m2
- The most common toxicities attributed to VSLI included peripheral neuropathy (55%) and constipation (53%)
- A CR was achieved in 7 of 36 patients (19%)
- The CR rate was 29% for the 14 patients who underwent therapy as their first salvage attempt
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