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NCT01118091 · ClinicalTrials.gov registry record · Phase 2
Prospective Randomized Comparative Study of Cell Transfer Therapy Using CD8+-Enriched Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Compared to High-Dose Aldesleukin in M...
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01118091: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01118091 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118091, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Background: \- Adoptive cell therapy involves taking white blood cells called lymphocytes from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient to allow the cells to attack the tumor. Because this process is lengthy and difficult to perform, researchers have been developing improved means of performing adoptive cell therapy. Researchers are now interested in comparing adoptive cell therapy with the standard treatment for metastatic melanoma (skin cancer). Objectives: \- To compare the effectiveness of adoptive cell therapy with standard high-dose aldesleukin as a treatment for metastatic melanoma. Eligibility: * Individuals 18 years of age or older who have been diagnosed with metastatic melanoma and have not previously received aldesleukin therapy or cell therapy for their disease. * Participants must have at least one tumor that can be easily removed as part of the treatment procedure. Design: * Participants will be screened with a full medical history, physical examination, blood and urine tests, and imaging scans to evaluate tumor size and treatment options. * Participants will be separated into two groups, in which one group will have adoptive cell therapy and one will have aldesleukin treatment. * Adoptive Cell Therapy * Participants will have a tumor sample taken in order to collect white blood cells for treatment. Participants whose tumors do not provide sufficient white blood cells may be switched to the aldesleukin-only treatment group. * The white blood cells will be grown in the laboratory for several weeks. * Prior to receiving cell therapy, participants will receive chemotherapy for 7 days to improve the chances of successful treatment. * Participants will have cell therapy followed by high-dose aldesleukin treatment every 8 hours for up to 5 days. This treatment will be followed by 1 to 2 weeks of recovery time as an inpatient at the clinical center. * Participants will
Interventions
- BIOLOGICAL Aldesleukin
- BIOLOGICAL CD8 enriched Young TIL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01118091
The ClinicalTrials.gov registry entry for NCT01118091 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 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 2 interventions - of which Aldesleukin is the first listed.
NCT01118091 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01118091 about?
NCT01118091 is a clinical study titled "Prospective Randomized Comparative Study of Cell Transfer Therapy Using CD8+-Enriched Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Compared to High-Dose Aldesleukin in M...". Background: \- Adoptive cell therapy involves taking white blood cells called lymphocytes from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient to allow the cells to attack the tumor. Because this process is lengthy and difficult to pe...
What is the current status of trial NCT01118091?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2010-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01118091?
The interventions under investigation include: Aldesleukin (BIOLOGICAL), CD8 enriched Young TIL (BIOLOGICAL).
Who is sponsoring clinical trial NCT01118091?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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