Phase I and pharmacokinetic study of once-daily dosing of intravenously administered busulfan in the setting of a reduced-intensity preparative regimen and allogeneic hematopoietic stem cell transplantation as immunotherapy for renal cell carcinoma

Paul Shaughnessy, Warren Alexander, Hai Tran, David Ririe, James Splichal, Marilyn Pollack, Carlos Bachier, Charles LeMaistre

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

We performed a Phase I and pharmacokinetic study of once-daily, intravenously administered busulfan in the setting of a reduced-intensity preparative regimen and matched sibling donor allogeneic stem cell transplantation for treatment of metastatic renal cell carcinoma. Seven male patients with metastatic renal cell carcinoma received intravenously administered busulfan at 3.2 mg/kg once daily on day -10 and day -9, fludarabine at 30 mg/m2 on day -7 through day -2, and equine antithymocyte globulin at 15 mg/kg per day on day -5 through day -2. The mean area under the plasma concentration-time curve (AUC) and the half-life of the first dose of intravenously administered busulfan were 6,253 μM-minute (range, 5,036-7,482 μM·minute) and 3.37 hours (range, 2.54-4.00 hours), respectively. The AUC was higher than predicted from extrapolation of AUC data for the same total dose of intravenously administered busulfan divided into four doses daily. Patients experienced greater than expected regimen-related toxicity for a reduced-intensity preparative regimen, and the study was stopped. In conclusion, this preparative regimen was associated with unacceptable regimen-related toxicity among patients with metastatic renal cell carcinoma.

Original languageEnglish (US)
Pages (from-to)161-165
Number of pages5
JournalMilitary medicine
Volume171
Issue number2
DOIs
StatePublished - Feb 2006

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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