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NCT00074269 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer
A Phase 2 study, sponsored by University of California, San Diego.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00074269 is a Phase 2 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 5 participants.
The verdict
NCT00074269, a Phase 2 study, was terminated before completion, sponsored by University of California, San Diego.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, cyclosporine, and methotrexate before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast.
Interventions
- BIOLOGICAL filgrastim
- DRUG cyclosporine
- BIOLOGICAL anti-thymocyte globulin
- BIOLOGICAL therapeutic allogeneic lymphocytes
- BIOLOGICAL graft-versus-tumor induction therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2003-07 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00074269
The ClinicalTrials.gov registry entry for NCT00074269 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which filgrastim is the first listed.
NCT00074269 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00074269 about?
NCT00074269 is a clinical study titled "Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer". RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune syste...
What is the current status of trial NCT00074269?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2003-07. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00074269?
The interventions under investigation include: filgrastim (BIOLOGICAL), cyclosporine (DRUG), anti-thymocyte globulin (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL), graft-versus-tumor induction therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT00074269?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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