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NCT00509496 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Anti-gp100:154-162 TCR Gene Engineered Lymphocytes
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00509496: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00509496 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00509496, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
Background: * Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type, human leukocyte antigen (HLA-A\*0201) derived from the gp100 protein. A retroviral vector was constructed that can deliver the TCR to cells. * This gene-engineered cell is over 10 times more reactive with melanoma cells than is the melanoma antigen recognized by T-cells (MART-1) TCR that resulted in tumor shrinkage for two patients with metastatic melanoma. Objectives: * To determine whether an anti-melanoma protein receptor 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 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 anti-gp100 protein is 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 anti-gp100. Patients receive an IV infusion of the treated cells containing anti-gp100 protein, followed by infusions of a drug called IL-2 (aldesleukin), 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
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- BIOLOGICAL aldesleukin
- BIOLOGICAL autologous anti-gp 100:154-162 T-cell receptor gene-engineered tumor infiltrating lymphocytes
- BIOLOGICAL autologous anti-gp 100:154-162 T-cell receptor gene-engineered peripheral blood lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00509496
The ClinicalTrials.gov registry entry for NCT00509496 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 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.
NCT00509496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00509496 about?
NCT00509496 is a clinical study titled "Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Anti-gp100:154-162 TCR Gene Engineered Lymphocytes". Background: * Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type, human leukocyte antigen (HLA-A\*0201) derived from the gp100 protein. A retroviral vector was constructed that can deliver the TCR to cells. * This gene-engineered ...
What is the current status of trial NCT00509496?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2007-06. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00509496?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), aldesleukin (BIOLOGICAL), autologous anti-gp 100:154-162 T-cell receptor gene-engineered tumor infiltrating lymphocytes (BIOLOGICAL), autologous anti-gp 100:154-162 T-cell receptor gene-engineered peripheral blood lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00509496?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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