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NCT00540995 · ClinicalTrials.gov registry record · Phase 1
Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00540995: Clinical Trial Phase 1 study, sponsored by City of Hope Medical Center.
NCT00540995 is a Phase 1 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00540995, a Phase 1 study, was terminated before completion, sponsored by City of Hope Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving intensity-modulated radiation therapy together with busulfan and etoposide before a transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy when given together with busulfan and etoposide followed by a donor stem cell transplant and to see how well it works in treating patients with advanced myeloid cancer.
Primary Outcome
The highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study treatment when at least six patients were treated at the dose and are evaluable for toxicity. The MDT is one dose level below the DLT level. At least six patients will be treated at the MTD.
Interventions
- RADIATION intensity-modulated radiation therapy
- DRUG etoposide
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- DRUG busulfan
- PROCEDURE allogeneic bone marrow transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-06-11 |
| Est. Completion | 2011-08-09 |
| Phase | Phase 1 |
Why NCT00540995 stopped before completion
NCT00540995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which intensity-modulated radiation therapy is the first listed.
NCT00540995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00540995 about?
NCT00540995 is a clinical study titled "Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer". RATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells...
What is the current status of trial NCT00540995?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2007-06-11. Estimated completion is 2011-08-09.
What interventions are being tested in trial NCT00540995?
The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), etoposide (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), busulfan (DRUG), allogeneic bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00540995?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00540995's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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