At a glance
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Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)
In Brief
A clinical study evaluating Palonosetron - Single Dose, Palonosetron - Triple Dose, and 6 other interventions for Sarcoma and 2 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be studied.
Study Details
Timeline
Interventions
0.25 mg by vein for 1 dose (day 0).
0.25 mg by vein for 3 doses (days 0, 2, 4).
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
750 mg/m2 as an IV bolus.
500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
2 mg IV by rapid administration on day 0 (for patients with small cell histology). For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only.
IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.