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NCT01955460 · ClinicalTrials.gov registry record · Phase 1
Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma
A Phase 1 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01955460: Active Phase 1 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
NCT01955460 is a Phase 1 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955460, a Phase 1 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot phase I trial studies the side effects and best dose of genetically modified T-cells followed by aldesleukin in treating patients with stage III-IV melanoma. T-cells are a type of white blood cell that help the body fight infections. Genes that may help the T-cells recognize melanoma cells are placed into the T-cells in the laboratory. Adding these genes to the T cells may help them kill more tumor cells when they are put back in the body. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells.
Primary Outcome
Feasibility of generating TGFa-DNRII and NGFR transduced TILs and safety of treating patients with genetically modified T cells will be assessed. Feasibility will be defined as the production of virally transduced T cells and treatment of patients with these cells.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- BIOLOGICAL Aldesleukin
- BIOLOGICAL NGFR-transduced Autologous T Lymphocytes
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-10-15 |
| Est. Completion | 2027-10-30 |
| Phase | Phase 1 |
What the registry record for NCT01955460 still lists
NCT01955460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (59% lower).
The record links to 6 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01955460 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01955460 about?
NCT01955460 is a clinical study titled "Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma". This pilot phase I trial studies the side effects and best dose of genetically modified T-cells followed by aldesleukin in treating patients with stage III-IV melanoma. T-cells are a type of white blood cell that help the body fight infections. Genes that may help the T-cells recognize melanoma cell...
What is the current status of trial NCT01955460?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2014-10-15. Estimated completion is 2027-10-30.
What conditions does trial NCT01955460 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage III Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT01955460?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Aldesleukin (BIOLOGICAL), NGFR-transduced Autologous T Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01955460?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01955460 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01955460's enrollment target sits among peer trials
34 52nd of 91 higher than 40 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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