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NCT01319565 · ClinicalTrials.gov registry record · Phase 2
Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI...
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT01319565: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01319565 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319565, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
Background: \- An experimental treatment for metastatic melanoma involves cell therapy, in which researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the laboratory in large numbers, and then use the cells to attack the tumor tissue. Before receiving the cells, chemotherapy is needed to temporarily suppress the immune system to improve the chances that the tumor-fighting cells will be able to survive in the body. In some studies of cell therapy, individuals who have received total body irradiation (TBI) in addition to the chemotherapy (in order to increase the length of time that they do not produce white blood cells) seem to have a slightly better response to the treatment, but it is not known if adding radiation to the cell therapy will cause a better response for all individuals. Researchers are interested in comparing cell therapy given with the usual chemotherapy to cell therapy given with the usual chemotherapy and TBI. Objectives: \- To compare the effectiveness of cell therapy given with chemotherapy to cell therapy given with chemotherapy and total body irradiation in individuals with metastatic melanoma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants will be divided into two groups: cell therapy with chemotherapy alone (group 1) or cell therapy with chemotherapy plus TBI (group 2). * All participants will provide a tumor sample from either surgery or a tumor biopsy for white blood cell collection. * Participants will have leukapheresis to collect additional white blood cells for cell growth and future testing, and TBI group participants will also provide stem cells to help them recover after radiation. (TBI participants who cannot provide enough stem cells will be moved to the non-radiation treatment group.) * Participants w
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- RADIATION Total Body Irradiation (TBI)
- DRUG Aldesleukin
- BIOLOGICAL Young TIL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2011-03-24 |
| Est. Completion | 2024-09-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319565
The ClinicalTrials.gov registry entry for NCT01319565 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 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.
NCT01319565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01319565 about?
NCT01319565 is a clinical study titled "Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI...". Background: \- An experimental treatment for metastatic melanoma involves cell therapy, in which researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the laboratory in large numbers, and then use the cells to attack the tumor tissue. Before receiving the cells, chemo...
What is the current status of trial NCT01319565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2011-03-24. Estimated completion is 2024-09-10.
What interventions are being tested in trial NCT01319565?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Total Body Irradiation (TBI) (RADIATION), Aldesleukin (DRUG), Young TIL (BIOLOGICAL).
Who is sponsoring clinical trial NCT01319565?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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