Peripheral Blood Stem Cell Transplantation in Children With High-Risk or Recurrent Solid Tumors
The optimal treatment for refractory (disease won't go away with standard treatment) or
relapsed (disease comes back after going away) solid tumors is unknown. Recent studies have
shown some benefit to tandem peripheral blood stem cell transplantation (PBSCT). In a tandem
transplant, two transplants are done, one after the other. To do a PBSCT, stem cells
("mother cells" that can become any other type of cell) are first collected from the
patient's circulating blood. The patient then undergoes high-dose chemotherapy called the
preparative regimen. The preparative regimen destroys not only the tumor cells, but it also
destroys all of the normal blood making cells. The collected cells are then given back to
the patient to "rescue" the patient from the devastating effects of the preparative regimen.
By using a stem cell rescue will are able to give much higher doses of chemotherapy than we
would be able to give without the stem cell rescue. To make sure that all of the tumor
cells are destroyed, patients in this study will undergo two separate transplants using two
different preparative regimens. The preparative regimens will use the best agents that
have been found to work against recurrent and refractory solid tumors: Busulfan, Thiotepa,
Cyclophosphamide and Melphalan.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility and toxicity of tandem high dose chemotherapy and peripheral blood stem cells rescue in patients with high-risk or recurrent solid tumors.
1 year after last patient is enrolled
Yes
Kuang-Yueh Chiang, MD
Principal Investigator
Emory University
United States: Institutional Review Board
PBSCT for ST
NCT00966498
May 2003
July 2011
Name | Location |
---|---|
Emory University | Atlanta, Georgia 30322 |
Children's Healthcare of Atlanta | Atlanta, Georgia 30342 |