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NCT00910650 · ClinicalTrials.gov registry record · Phase 2
Study of Gene Modified Immune Cells in Patients With Advanced Melanoma
A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00910650 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 14 participants.
The verdict
NCT00910650, a Phase 2 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this phase 2 study is to find the best way to give this new experimental regimen and determine if it can treat metastatic melanoma in humans. In this phase 2 study, the experimental products are given initially to a group of 8 people. If safe and found to have significant anti-tumor activity, it will be given to up to 14 other people, for a total of 22 people in this study. Physicians watch subjects carefully for any harmful side effects. Although the experimental regimen has been well tested in laboratory and animal studies, and a similar regimen has been given to a group of patients at the National Cancer Institute in Bethesda, MD, the side effects in people cannot be completely known ahead of time. This protocol is offered only to people whose condition cannot be helped by other known treatments. The study procedures will start with the collection of white blood cells through apheresis (a procedure in which blood is drawn from a patient and separated into its components, some of which are retained, such as white blood cells, and the remainder returned by transfusion to the patient). Subjects will be asked to undergo two aphereses, one to make the gene-modified MART-1 TCR CTLs (cytolytic T lymphocyte) and the dendritic cell vaccines, and a second one after the subject receives the gene modified cells to later study them in the blood. On the day of the first apheresis, subjects will be admitted to the hospital and will receive chemotherapy over the next five days which decreases the risk of rejection of the transferred cells by the subject's immune system and facilitates their expansion and attack of the melanoma lesions. During this time, the gene-modified MART-1 TCR CTLs and the dendritic cells will be manufactured in the laboratory from the apheresis product and will be extensively tested to assure that they express the appropriate TCR and that they do not contain any contaminating bacteria or virus. Then the gene-modified MART-1 TCR CTLs will
Interventions
- BIOLOGICAL F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells
- DRUG non-myeloablative conditioning chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-10-13 |
| Est. Completion | 2019-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00910650
The ClinicalTrials.gov registry entry for NCT00910650 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells is the first listed.
NCT00910650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00910650 about?
NCT00910650 is a clinical study titled "Study of Gene Modified Immune Cells in Patients With Advanced Melanoma". The purpose of this phase 2 study is to find the best way to give this new experimental regimen and determine if it can treat metastatic melanoma in humans. In this phase 2 study, the experimental products are given initially to a group of 8 people. If safe and found to have significant anti-tumor a...
What is the current status of trial NCT00910650?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2009-10-13. Estimated completion is 2019-05-30.
What interventions are being tested in trial NCT00910650?
The interventions under investigation include: F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells (BIOLOGICAL), non-myeloablative conditioning chemotherapy (DRUG).
Who is sponsoring clinical trial NCT00910650?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
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