Spots Global Cancer Trial Database for Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
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Trial Identification
Brief Title: Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
Official Title: A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation
Study ID: NCT00393380
Interventions
Study Description
Brief Summary: The purpose of this study is to determine whether the addition of parathyroid hormone after a sequential cord blood transplant will improve engraftment, which is the ability of the transplanted stem cells to grow and to successfully begin producing new blood cells.
Detailed Description: In this phase II, single stage study, participants will include 40 adults who are candidates for a hematopoietic stem cell transplant. All participants will undergo a sequential cord blood transplant using a well-known myeloablative regimen of fludarabine, cyclophosphamide, and total body irradiation, which is appropriate for those individuals who are likely to benefit from an ablative regimen. Tacrolimus will be combined with mycophenolate mofetil (MMF) for the graft-versus-host disease (GVHD) prophylaxis regimen. Parathyroid hormone (PTH) will be added to this regimen in an attempt to improve engraftment. PTH is an approved drug with minimal side effects in individuals with osteoporosis; the dose of PTH has been determined from a phase I study in individuals with hematologic cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Florida, Gainesville, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Contact Details
Name: Karen K. Ballen, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Joseph Antin, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: David Avigan, MD
Affiliation: Beth Israel Deaconess Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Elizabeth J Shpall, MD
Affiliation: MD Anderson Cancer Research Center
Role: PRINCIPAL_INVESTIGATOR
Name: Colleen Delaney, MD
Affiliation: Fred Hutchinson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ram Kamble, MD
Affiliation: Baylor College of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Katarzyna Jamieson, M.D.
Affiliation: University of Florida
Role: PRINCIPAL_INVESTIGATOR
Name: Philip McCarthy, M.D.
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Edward Ball, M.D.
Affiliation: University of California, San Diego
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Maziarz, M.D.
Affiliation: Oregon Health and Science University
Role: PRINCIPAL_INVESTIGATOR
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