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NCT00923845 · ClinicalTrials.gov registry record · Phase 2
Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00923845: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00923845 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923845, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background: Low-dose chemotherapy is easier for the body to tolerate than typical high-dose chemotherapy and involves a shorter period of complete immune suppression. Donor immune cells called lymphocytes, or T cells, fight residual tumor cells that might have remained in the recipients body after stem cell transplant, in what is called a graft-versus-tumor (GVT) effect. The immune-suppressing drug sirolimus appears to help prevent graft-versus-host disease (GVHD), a side effect of stem cell transplant in which donated T cells sometimes attack healthy tissues, damaging organs such as the liver, intestines and skin. Th2 cells are cells collected from the transplant donor and grown in a high concentration of sirolimus. Objectives: To determine whether stem cell transplantation using low-dose chemotherapy and sirolimus-generated Th2 cells can cause a remission of advanced kidney cancer. Eligibility: Patients between 18 and 75 years of age who have kidney cancer that has spread beyond the kidney and who have a tissue-matched sibling stem cell donor. Design: Patients undergo stem cell transplantation as follows: * Low-intensity chemotherapy with pentostatin and cyclophosphamide over a 21-day period to reduce the level of the immune system to prepare for the transplant. Pentostatin is given through a vein (intravenous (IV)) on days 1, 8 and 15; cyclophosphamide tablets are taken by mouth for 21 consecutive days. * Sirolimus tablets, taken by mouth, starting 2 days before the transplant and continuing until 60 days after the transplant. * IV infusions of stem cells and Th2 cells. Following the transplant, patients have the following procedures: * Additional Th2 cell infusions on days 14 and 45 after the transplant. * Follow-up visits at the National Institutes of Health (NIH) Clinical Center twice a week for the first 6 months after the transplant and then less frequently for at least 5 years to evaluate response to treatment and treatment side effects. Evalua
Interventions
- DRUG Cyclophosphamide
- DRUG Sirolimus
- DRUG Pentostatin
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
- PROCEDURE Th2 rapa cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-03-01 |
| Est. Completion | 2017-06-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923845
The ClinicalTrials.gov registry entry for NCT00923845 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT00923845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923845 about?
NCT00923845 is a clinical study titled "Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer". Background: Low-dose chemotherapy is easier for the body to tolerate than typical high-dose chemotherapy and involves a shorter period of complete immune suppression. Donor immune cells called lymphocytes, or T cells, fight residual tumor cells that might have remained in the recipients body after...
What is the current status of trial NCT00923845?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2008-03-01. Estimated completion is 2017-06-22.
What interventions are being tested in trial NCT00923845?
The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG), Pentostatin (DRUG), Allogeneic Hematopoietic Stem Cell Transplant (HSCT) (PROCEDURE), Th2 rapa cells (PROCEDURE).
Who is sponsoring clinical trial NCT00923845?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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