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NCT01369888 · ClinicalTrials.gov registry record · Phase 1
Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01369888: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01369888 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369888, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: \- Researchers have developed an experimental cancer treatment called cell therapy. White blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab, and then given back to the patient. Interleukin-15, given to the patient after the cells (now called Young tumor-infiltrating lymphocytes of Young TIL cells) are replaced, helps the cells to grow and boosts the immune system. This process changes your normal cells into cells that are able to recognize your tumor has been studied in the lab. These cells can destroy tumor cells in the test tube, but scientists want to see if they work inside the body. Objectives: -To test the effectiveness of lymphocytes drawn from tumor cells combined with interleukin-15 in treating metastatic melanoma. Eligibility: * Patients must be 18 - 66 years of age and have a diagnosis of metastatic melanoma. * They will have heart and lung function tests, lab tests, and imaging procedures. * Patients may not have conditions such as active systemic infections, blood clotting disorders, or other active major medical illnesses. * Patients may not be pregnant or nursing.
Primary Outcome
Intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL with dose escalation (i.e., dose level 1: 0.25 mcg, dose level 2: 0.50 mcg, dose level 3: 1 mcg, and dose level 4: 2 mcg) to further characterize the safety of the MTD prior to starting the phase 2 portion.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Tumor Infiltrating Lymphocytes
- DRUG IL-15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
Why NCT01369888 stopped before completion
NCT01369888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01369888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369888 about?
NCT01369888 is a clinical study titled "Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma". Background: \- Researchers have developed an experimental cancer treatment called cell therapy. White blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab, and then given back to the patient. Interleukin-15, given to the patient after the cells (now called Young ...
What is the current status of trial NCT01369888?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-05. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01369888?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Tumor Infiltrating Lymphocytes (BIOLOGICAL), IL-15 (DRUG).
Who is sponsoring clinical trial NCT01369888?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369888's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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