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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 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 11 participants.

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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.

Interventions

  • DRUG fludarabine phosphate
  • DRUG cyclosporine
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil
  • PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2000-02
Est. Completion 2018-09-27
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT00005851

The ClinicalTrials.gov registry entry for NCT00005851 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT00005851 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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