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NCT01236573 · ClinicalTrials.gov registry record · Phase 1
Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01236573: Clinical Trial Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT01236573 is a Phase 1 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01236573, a Phase 1 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: \- One experimental treatment for certain types of cancer is cell therapy, which involves collecting lymphocytes (white blood cells) from a tumor, growing them in the laboratory in large numbers, and then modifying the cells with a gene (interleukin-12 (IL-12)) that stimulates the immune system to attack and destroy the cancer cells. Because this treatment is experimental, researchers are interested in determining the side effects and overall effectiveness of cell therapy using white blood cells modified with IL-12 as a treatment for aggressive cancer. Objectives: \- To determine the safety and effectiveness of cell therapy using IL-12 modified tumor white blood cells to treat metastatic melanoma. Eligibility: \- Individuals greater than or equal to 18 years of age and less than or equal to age 66 who have been diagnosed with metastatic melanoma. Design: * Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies. * Cells for treatment will be collected during tumor biopsy or surgery. * Prior to the start of cell therapy, participants will have imaging procedures, heart and lung function tests, and blood and urine tests, as well as leukapheresis to collect additional white blood cells. * For 5 days before the cell infusion, participants will be admitted for inpatient chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in preparation for the cell therapy. * Participants will receive the modified white blood cells as an infusion 1 to 4 days after the last dose of chemotherapy. The day after the infusion, participants will receive filgrastim to stimulate blood cell growth. * Participants will remain as inpatients for at least 5 to 10 days to recover from the treatment, and will be followed regularly after the treatment to study side effects and general effectiveness. * Participants who initially respond to treatment but have a relapse may have one additional tre
Primary Outcome
The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10\^6, 3x10\^6, 3x10\^7, 1x10\^7, 3x10\^7, 1x10\^8, 3x10\^8, 1x10\^9, and 3x10\^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which \</= 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)).
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL IL-12 transduced TIL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
Why NCT01236573 stopped before completion
NCT01236573 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01236573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01236573 about?
NCT01236573 is a clinical study titled "Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes". Background: \- One experimental treatment for certain types of cancer is cell therapy, which involves collecting lymphocytes (white blood cells) from a tumor, growing them in the laboratory in large numbers, and then modifying the cells with a gene (interleukin-12 (IL-12)) that stimulates the immun...
What is the current status of trial NCT01236573?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-10. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01236573?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), IL-12 transduced TIL (BIOLOGICAL).
Who is sponsoring clinical trial NCT01236573?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01236573's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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