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NCT00984165 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Radiation-Enhanced Allogeneic Cell Therapy for Progressive Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00984165: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00984165 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00984165, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Background: * Allogeneic hematopoietic stem cell transplantation (allotransplant) has been used to treat many kinds of cancer that develop in cells from the blood or immune system. After allotransplant, donor cells take over production of the recipient s blood and immune cells, and donor immune cells can directly attack and control tumor. However, for cancers that do not respond to allotransplant, there are no proven cures. * A single treatment with radiation can improve the potency of immune-cell therapies. This is probably because the tumor tissue is damaged in a way that new tumor proteins are exposed, attracting immune cells to the tumor. By giving only a single dose of radiation, the immune cells that are attracted to the tumor are allowed to survive and function in their usual way, traveling throughout the body and educating other immune cells to recognize tumor, and to activate and expand in order to kill the tumor cells. Some research has shown that radiation may have a widespread effect on stimulating the immune system, educating immune cells to recognize and control tumors that have not been radiated. Objectives: \- To determine whether a single treatment of radiation will help donor immune cells control cancer after allotransplant without causing excessive side effects. Eligibility: * Recipients: Individuals 18 years of age and older who have blood cancers that have not responded to allotransplant. * Donors: Healthy individuals 18 years of age and older who were previous allotransplant donors for one of the study recipients. Design: * Donors will provide additional blood immune cells, called lymphocytes, through apheresis. Apheresis involves drawing blood, separating out the lymphocytes, and returning the rest of the blood to the donor. * Recipients will receive a single dose of radiation to the greatest amount of tumor that can be irradiated safely. Researchers will intentionally leave some tumor that will not be radiated in order to evaluate whet
Interventions
- PROCEDURE Apheresis
- BIOLOGICAL Donor Lymphocyte Infusion (DLI)
- PROCEDURE Single fraction radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-01-19 |
| Est. Completion | 2013-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00984165
The ClinicalTrials.gov registry entry for NCT00984165 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 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 3 interventions - of which Apheresis is the first listed.
NCT00984165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00984165 about?
NCT00984165 is a clinical study titled "Pilot Study of Radiation-Enhanced Allogeneic Cell Therapy for Progressive Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation". Background: * Allogeneic hematopoietic stem cell transplantation (allotransplant) has been used to treat many kinds of cancer that develop in cells from the blood or immune system. After allotransplant, donor cells take over production of the recipient s blood and immune cells, and donor immune cel...
What is the current status of trial NCT00984165?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2010-01-19. Estimated completion is 2013-01-31.
What interventions are being tested in trial NCT00984165?
The interventions under investigation include: Apheresis (PROCEDURE), Donor Lymphocyte Infusion (DLI) (BIOLOGICAL), Single fraction radiation (PROCEDURE).
Who is sponsoring clinical trial NCT00984165?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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