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NCT00513604 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT00513604: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00513604 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 158 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513604, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study Summary
Background: * Most therapeutic therapies for metastatic melanoma have focused on the ability of T-cell lymphocytes to kill cells of tumors. * An adaptive cell transfer therapy has been pioneered, in which cells are grown for a short time in the laboratory. The way they are grown may have a better effect in a patient's body than do other cells that are cultured for a longer time. Objectives: * To determine whether tumor-infiltrating lymphocytes (TIL) can be put in cells removed from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors. * To evaluate safety and effectiveness of the treatment. Eligibility: * Patients 18 years of age or older with metastatic cancer melanoma (cancer that has spread beyond the original site). * Patient's leukocyte antigen type is human leukocyte antigens (HLA-A) 0201. Design: -Patients undergo the following procedures: * Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the TIL cells (called young TIL cells) are inserted into the cells using an inactivated (harmless) virus in a process called retroviral transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. * Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1 hour for 2 days to suppress the immune system so that the patient's immune cells do not interfere with the treatment. * Treatment with young TIL cells. Patients receive an IV infusion of the treated cells, followed by infusions the drug aldesleukin-2 (IL-2), which helps boost the effectiveness of the treated white cells. * Patients are given support medications to prevent complications such as infections. * Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). * Patients are evaluated with laboratory tests and imaging test
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine phosphate
- RADIATION Total body irradiation
- BIOLOGICAL therapeutic autologous lymphocytes
- BIOLOGICAL aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00513604
The ClinicalTrials.gov registry entry for NCT00513604 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 158 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.
NCT00513604 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00513604 about?
NCT00513604 is a clinical study titled "Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma". Background: * Most therapeutic therapies for metastatic melanoma have focused on the ability of T-cell lymphocytes to kill cells of tumors. * An adaptive cell transfer therapy has been pioneered, in which cells are grown for a short time in the laboratory. The way they are grown may have a better e...
What is the current status of trial NCT00513604?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2007-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00513604?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine phosphate (DRUG), Total body irradiation (RADIATION), therapeutic autologous lymphocytes (BIOLOGICAL), aldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00513604?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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