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NCT00079625 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplant With Th2/Tc2 Cells to Treat Advanced Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00079625: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00079625 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079625, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This Phase 1 trial will investigate the safety of a modified stem cell transplant procedure for treating advanced breast cancer. Patients with cancers can sometimes benefit greatly from transplants of stem cells (cells produced by the bone marrow that mature into blood cells). In addition to producing new bone marrow and restoring normal blood production and immunity, the donated cells fight any residual tumor cells that might have remained in the body, in what is called a "graft-versus-tumor" effect. However, severe problems, or sometimes even death, may follow these transplants as a result of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune cells called lymphocytes, or T cells, sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD), damaging organs such as the liver, intestines and skin. This study will use the following strategies to try to reduce these risks: * "Induction chemotherapy" to reduce patients' immunity in an attempt to prevent rejection of the donated stem cells * Reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and involves a shorter period of complete immune suppression * Removal of lymphocytes from the donor stem cells for transfusion in small quantities at monthly intervals following the stem cell transplant to reduce the risk of GVHD * Transplant of specific lymphocytes called Th2/Tc2 cells that may increase the percentage of donor stem cells accepted by the patient without significantly increasing GVHD Patients between 18 and 75 years of age with advanced (stage IV) breast cancer that does not respond to standard therapy may be eligible for this study. Candidates are screened with a medical history, physical and dental examinations, x-ray studies and bone marrow biopsies to evaluate disease status, blood and urine tests (including a blood test for genetic match with the donor), and lung and heart function tests. Participants have a c
Interventions
- DRUG Th2/Tc2 Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2004-03-05 |
| Est. Completion | 2013-08-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00079625
The ClinicalTrials.gov registry entry for NCT00079625 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Th2/Tc2 Cells is the first listed.
NCT00079625 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00079625 about?
NCT00079625 is a clinical study titled "Stem Cell Transplant With Th2/Tc2 Cells to Treat Advanced Breast Cancer". This Phase 1 trial will investigate the safety of a modified stem cell transplant procedure for treating advanced breast cancer. Patients with cancers can sometimes benefit greatly from transplants of stem cells (cells produced by the bone marrow that mature into blood cells). In addition to produci...
What is the current status of trial NCT00079625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2004-03-05. Estimated completion is 2013-08-09.
What interventions are being tested in trial NCT00079625?
The interventions under investigation include: Th2/Tc2 Cells (DRUG).
Who is sponsoring clinical trial NCT00079625?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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