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Prince et al.<br />

Table 1. High-dose regimens (planned three cycles)<br />

Regimens<br />

MT<br />

Melphalan<br />

Thiotepa<br />

ITP (Phase I study)<br />

307<br />

Dose/cycle Patients (n) Total cycles delivered<br />

100 mg/m 2<br />

200 mg/m 2<br />

2 6<br />

Ifosfamide 10-12.5 g/m 2 23 59<br />

Thiotepa<br />

Paclitaxel<br />

200-350 mg/m 2<br />

175 mg/m 2<br />

ITP with Isolex300i CD34 selection<br />

Ifosfamide 10 g/m 2 14* 36<br />

Thiotepa<br />

Paclitaxel<br />

CTP<br />

Cyclophosphamide<br />

Thiotepa<br />

Paclitaxel<br />

300 mg/m 2<br />

175 mg/m 2<br />

4 g/m 2<br />

350 mg/m 2<br />

175 mg/m 2<br />

3 8<br />

Total 42 109<br />

*Eight underwent CD34 selection.<br />

ifosfamide/mesna infusion, mesna (20% wt/wt of the ifosfamide dose) was<br />

administered intravenously over 8 hours. Thiotepa was administered in equally<br />

divided doses on days -4, -3, <strong>and</strong> -2. Paclitaxel (175 mg/m 2<br />

) was administered as<br />

a 3-hour infusion on day -2. Cryopreserved PBPC were thawed <strong>and</strong> infused on day<br />

0. All patients received recombinant human (rh)G-CSF (filgrastim; Neupogen,<br />

Amgen Australasia, Sydney, Australia) (5 pg/kg/d) subcutaneously from day 1<br />

until the ANC was >1.5X10 9<br />

/L for 3 consecutive days. All patients received<br />

prophylactic ciprofloxacin, acyclovir, <strong>and</strong> ranitidine. The MTD was defined when<br />

two or more patients developed National Cancer Institute (NCI) grade 4 nonhematologic<br />

toxicity (excluding alopecia) or grade 3 neurologic, cardiac, or renal<br />

toxicity or when two or more patients were unable to receive further high-dose<br />

therapy because of hematologic toxicity.<br />

Phase II Isolex300i CD34-selection study (n=14). To date, 14 patients have<br />

been enrolled in a phase II study involving CD34-selection of PBPCs. Briefly, in<br />

patients from whom >12X 10 6<br />

/kg CD34 +<br />

cells were obtained on a single day or on<br />

two consecutive days of collections (n=8), cells underwent CD34 +<br />

paramagnetic<br />

selection using the Isolex300i (Baxter Healthcare, Irvine, CA). After selection, the<br />

cells were divided <strong>and</strong> cryopreserved in the same way as described above. The total<br />

volume of CD34-selected cells infused following each cycle was 20 mL. A

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