Spots Global Cancer Trial Database for Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
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Trial Identification
Brief Title: Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Official Title: Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
Study ID: NCT00299780
Interventions
Study Description
Brief Summary: The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Karen Ballen, M.D.
Affiliation: Massachusetts General Hospital, Harvard University
Role: PRINCIPAL_INVESTIGATOR
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