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NCT02650986 · ClinicalTrials.gov registry record · Phase 1
Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by Roswell Park Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02650986: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by Roswell Park Cancer Institute.
NCT02650986 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Melanoma that is active but no longer recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 15 participants, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02650986, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Melanoma, is active but no longer recruiting, sponsored by Roswell Park Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving gene-modified T cells with or without decitabine works better in treating patients with malignancies expressing NY-ESO-1.
Primary Outcome
Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Leukapheresis
- BIOLOGICAL TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2032-07-14 |
| Phase | Phase 1 |
What the registry record for NCT02650986 still lists
NCT02650986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02650986 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02650986 about?
NCT02650986 is a clinical study titled "Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1". This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advance...
What is the current status of trial NCT02650986?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-07-14. Estimated completion is 2032-07-14.
What conditions does trial NCT02650986 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Advanced Melanoma.
What interventions are being tested in trial NCT02650986?
The interventions under investigation include: Cyclophosphamide (DRUG), Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Leukapheresis (PROCEDURE), TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT02650986?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02650986 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02650986's enrollment target sits among peer trials
15 97th of 108 higher than 12 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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