Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00966498|
Recruitment Status : Terminated (poor enrollment)
First Posted : August 27, 2009
Last Update Posted : December 11, 2013
Before the transplant, the patient will have a pre-transplant evaluation. This will help find out whether there are health problems that will prevent the transplant. It also provides "baseline" tests that will be used later to see whether or not organs have gotten better or worse after the transplant. Prior to the stem cell collection, the patient will get chemotherapy to help try to put him/her in remission and to push more stem cells into the peripheral blood (mobilization). The study doctor will decide which chemotherapy will be used for this part of the study. Once mobilization is completed, the peripheral blood stem cell collection (apheresis) will be done in the clinic. The apheresis machine will draw blood out of the central line. The blood then passes through the apheresis machine and the stem cells are separated out. The remaining blood is sent back through the central line. If the investigators are unable to collect enough peripheral blood stem cells, a bone marrow harvest may be necessary to collect more stem cells.
The patient will then be admitted to the hospital for the first transplant. He/she will get Thiotepa and Cyclophosphamide. Then the patient will be given back the cells that were collected. The cells are given in the same manner as a blood transfusion. The patient will be kept in the hospital until he/she is stable and blood counts are increasing. Approximately 6 to 8 weeks after Day 0 of the 1st transplant, the patient will be admitted for the second transplant. At this time, he/she will get Busulfan and Melphalan and then the collected cells will be given back. The patient will be kept in the hospital until he/she is stable and blood counts are increasing. Frequent clinic follow-up is required.
This study is open to patients who are less then 21 years of age with refractory or relapsed high-risk, solid tumors, excluding neuroblastoma (there is a cooperative group trial for these patients). Patients will be identified by the Transplant team and eligibility will be verified by a member of the clinical research team. Patients will be cared for by members of the Transplant team and various other subspecialty physicians.
|Condition or disease||Intervention/treatment||Phase|
|High Risk Solid Tumors Recurrent Solid Tumors||Procedure: Peripheral Blood Stem Cell Transplant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peripheral Blood Stem Cell Transplantation in Children With High-Risk or Recurrent Solid Tumors|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
This study is a single-arm, non-randomized trial. Peripheral blood stem cells will be harvested by mobilization with chemotherapy followed by G-CSF. Following adequate peripheral blood stem cell collection, the patients would be transplanted using the conditioning regimen consisting of thiotepa and cyclophosphamide (tandem one) and busulfan and melphalan (tandem two). They will receive G-CSF post transplant. There will be 6-8 weeks interval between tandem transplants. All patients would be carefully observed for any toxicity, transplant-related complications, relapse and disease-free survival.
Procedure: Peripheral Blood Stem Cell Transplant
Peripheral Blood Stem Cell Transplant
- 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. [ Time Frame: 1 year after last patient is enrolled ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966498
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kuang-Yueh Chiang, MD||Emory University|