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NCT01740557 · ClinicalTrials.gov registry record · Phase 1
Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01740557: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01740557 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01740557, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase I/II trial studies how well genetically modified therapeutic autologous lymphocytes (patient's own white blood cells) followed by aldesleukin work in treating patients with stage III melanoma or melanoma that has spread to other places in the body (metastatic). Placing chemokine (C-X-C motif) receptor 2 (CXCR2) and nerve growth factor receptor (NGFR) into lymphocytes (white blood cells) may help the body build an immune response to kill melanoma cells. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells. Giving genetically modified therapeutic autologous lymphocytes together with aldesleukin may be a better treatment for melanoma.
Primary Outcome
Response will be defined as a 50% or greater decrease in the tumor's linear dimension post treatment, compared to baseline. Response will be evaluated by positron emission tomography or computed tomography imaging.
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- BIOLOGICAL Aldesleukin
- BIOLOGICAL CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-01-28 |
| Est. Completion | 2023-04-21 |
| Phase | Phase 1 |
What the finished NCT01740557 record still lists
NCT01740557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01740557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01740557 about?
NCT01740557 is a clinical study titled "Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma". This phase I/II trial studies how well genetically modified therapeutic autologous lymphocytes (patient's own white blood cells) followed by aldesleukin work in treating patients with stage III melanoma or melanoma that has spread to other places in the body (metastatic). Placing chemokine (C-X-C mo...
What is the current status of trial NCT01740557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-01-28. Estimated completion is 2023-04-21.
What interventions are being tested in trial NCT01740557?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Aldesleukin (BIOLOGICAL), CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01740557?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01740557's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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