This was a Phase 1 dose escalating study in 36 healthy children aged 2 3 years started in March 2006 in Donéguébougou, Mali.
A dose escalating study of Vorinostat in 41 patients AML was recently reported.
Thirty-one women with colposcopically and histologically diagnosed microinvasive or pre-invasive cervical cancer were enrolled in a dose escalating study.
A phase I/II dose escalating study in previously treated metastatic breast cancer [ 68] identified an overall response rate of 6.7% and a median duration of response of 5.5 months.
In a dose escalating study, the maximal tolerated dose (MTD) was defined at five i.p. infusions of 10, 20, 50, 200, and 200 µg, administered within 9 13 days [ 12].
A dose escalating study of (up to 1600 μ g) IVT injection of siRNA in 26 patients showed tolerability and stabilization or improvement of VA in cases with neovascular AMD refractory to other types of treatment [ 28 ].
In a phase I dose escalating study, 28 patients with neovascular AMD were given a single IVT injection of 0.05 mg, 0.15 mg, 0.5 mg, 1.0 mg, 2.0 mg, and 3.0 mg KH902 and followed up for 12 weeks.
In a dose escalating study, Stanton et al 72 compared the effects of aliskiren (37.5 300 mg od) to that of losartan 100 mg in 226 patients with mild to moderate hypertension (mean daytime ambulatory SBP ≥ 140 mmHg) during 4 weeks of treatment.
In a dose escalating study at the MD Anderson, Pollack and co-workers found a volume dependency of the rectum toxicity (rectum volume irradiated with > 70 Gy, toxicity of grade II or higher after 5 years was 13% or 51% by ≤25% or >25% rectum volume, respectively [ 8].
In the present dose escalating study we show that standard radiotherapy can be safely combined with high doses of two drugs, namely Stealth® liposomal doxorubicin (Caelyx®) and Docetaxel (Taxotere®), if subcutaneous amifostine is used as a broad spectrum cytoprotective agent (Koukourakis et al, 2000a).
