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NCT00005851 · ClinicalTrials.gov registry record · Phase 1
Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Stage IV Kidney Cancer
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00005851: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00005851 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005851, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The reason for doing this study is to see if cancer will respond to immune therapy after transplantation of blood stem cells (from the bone marrow) using a new kind of treatment regimen that is less toxic than that previously used for blood stem cell transplants. This type of transplant uses much less chemotherapy and radiation than standard bone marrow transplants. The treatment consists of medications that weaken the immune system so it doesn't reject the donor's marrow cells. Researchers hope that the immune cells from the donor will attack the tumor. This is called a "graft versus tumor" effect and has been seen in other types of cancer. In addition, 65 days or more after the transplant the patient may be eligible for an immune treatment that uses additional immune cells from the donor to increase the effect of the stem cells against the cancer.
Primary Outcome
If 6 or more out of 25 patients achieve a CR or PR, then there is at least 80% confidence that the true response rate exceeds 15% and that this approach is potentially efficacious.
Interventions
- DRUG fludarabine phosphate
- DRUG cyclosporine
- RADIATION total-body irradiation
- DRUG mycophenolate mofetil
- PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2000-02 |
| Est. Completion | 2018-09-27 |
| Phase | Phase 1 |
What the finished NCT00005851 record still lists
NCT00005851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00005851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005851 about?
NCT00005851 is a clinical study titled "Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Stage IV Kidney Cancer". The reason for doing this study is to see if cancer will respond to immune therapy after transplantation of blood stem cells (from the bone marrow) using a new kind of treatment regimen that is less toxic than that previously used for blood stem cell transplants. This type of transplant uses much le...
What is the current status of trial NCT00005851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2000-02. Estimated completion is 2018-09-27.
What interventions are being tested in trial NCT00005851?
The interventions under investigation include: fludarabine phosphate (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG), nonmyeloablative allogeneic hematopoietic stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00005851?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005851's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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