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Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies
NCT01697527 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial will examine whether genetically reprogramming a patient's disease fighting white blood cells may build an immune response to kill cancer cells that express the NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein and may help to stimulate the engineered immune response to tumor cells.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- BIOLOGICAL aldesleukin
- BIOLOGICAL NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL
Study Locations (1)
California
- University of California at Los Angeles (UCLA ) — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-11-02 |
| Est. Completion | 2027-11-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697527
The ClinicalTrials.gov registry entry for NCT01697527 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 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 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which laboratory biomarker analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01697527 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01697527 about?
NCT01697527 is a clinical study titled "Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies". This phase II trial will examine whether genetically reprogramming a patient's disease fighting white blood cells may build an immune response to kill cancer cells that express the NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell transplant along with a vaccine ...
What is the current status of trial NCT01697527?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-11-02. Estimated completion is 2027-11-02.
What conditions does trial NCT01697527 study?
This clinical trial studies the following conditions: Malignant Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01697527?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cyclophosphamide (DRUG), fludarabine phosphate (DRUG), aldesleukin (BIOLOGICAL), NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01697527?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01697527 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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