Treatment plan
CNL, toxicity, Cancer
DISEASE PROGRESSION, INFUSION REACTION, CANCER
This was a multi-center trial performed at the University of Maryland Greenebaum Comprehensive Cancer Center, the University of Virginia Emily Couric Cancer Center, and the Medical University of South Carolina Fred Hollings Cancer Center. This study was approved by the institutional review board at each participating site and conducted in accordance with the ethical standards established in the Declaration of Helsinki.CNL was administered intravenously in a 250 mL bag of normal saline solution over approximately 2 h. It was given twice weekly on Mondays and Thursdays continuously until disease progression or unacceptable toxicity. One cycle was defined as 4 weeks of therapy. To minimize the risk of an infusion reaction observed with other lipid formulations, premedication with dexamethasone (20 mg), diphenhydramine (25 mg) and famotidine (20 mg) was given intravenously 30 min prior to each CNL infusion.The study used an accelerated titration design to minimize patient exposure to subtherapeutic dose levels and allow rapid dose escalation. The initial dose level (dose level 1) was 36 mg/m