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NCT01081808 · ClinicalTrials.gov registry record · Phase 1
Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors
A Phase 1 study, sponsored by Roger Williams Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01081808 is a Phase 1 study that was terminated before completion, run by Roger Williams Medical Center. The registered enrollment target is 2 participants.
The verdict
NCT01081808, a Phase 1 study, was terminated before completion, sponsored by Roger Williams Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic advanced solid tumors.
Interventions
- BIOLOGICAL EGFRBi-armed autologous activated T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01081808
The ClinicalTrials.gov registry entry for NCT01081808 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roger Williams Medical Center, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EGFRBi-armed autologous activated T cells is the first listed.
NCT01081808 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01081808 about?
NCT01081808 is a clinical study titled "Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors". RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells fo...
What is the current status of trial NCT01081808?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2009-10. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01081808?
The interventions under investigation include: EGFRBi-armed autologous activated T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01081808?
This trial is sponsored by Roger Williams Medical Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
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