Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
Patients will start treatment within 21 days of the determination of inadequate
mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg.
PTH will be given on day 1 and continue until stem cell collections are complete or a
maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem
cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off
study criteria and not continue with PTH/G-CSF.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
Karen Ballen, M.D.
Massachusetts General Hospital, Harvard University
United States: Institutional Review Board
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|