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NCT00966498 · ClinicalTrials.gov registry record · NA
Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors
A NA study, sponsored by Emory University.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT00966498 is a NA study that was terminated before completion, run by Emory University. The registered enrollment target is 3 participants.
The verdict
NCT00966498, a NA study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
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
Interventions
- PROCEDURE Peripheral Blood Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2003-05 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00966498
The ClinicalTrials.gov registry entry for NCT00966498 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Peripheral Blood Stem Cell Transplant is the first listed.
NCT00966498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00966498 about?
NCT00966498 is a clinical study titled "Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors". 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 transplan...
What is the current status of trial NCT00966498?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2003-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00966498?
The interventions under investigation include: Peripheral Blood Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00966498?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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