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NCT02327390 · ClinicalTrials.gov registry record · Phase 1
Ex Vivo-Activated Lymph Node Lymphocytes in Treating Patients With Stage IIIC-IV Melanoma
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02327390: Clinical Trial Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT02327390 is a Phase 1 study that was terminated before completion, run by Case Comprehensive Cancer Center. 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
NCT02327390, a Phase 1 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase I trial studies the safety and best dose of ex-vivo activated lymph node lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's lymph node(s) close to a melanoma tumor. These lymph nodes contain special kind of cells (called T cells) which can be activated (getting the cells to start up certain responses in the immune system) outside of the body in an approved laboratory. The activated T cells are then injected back into the same participant using an i.v. to help the participant's immune system to target melanoma. The participant will undergo regular blood testing to determine whether the X-ACT treatment has resulted in changes to the immune system and also whether the T cells which were given back to the patient persist in the blood stream over time. In addition, the effect of the X-ACT treatment on the growth or shrinkage of the participant's melanoma will be measured.
Primary Outcome
Number of patients with dose-limiting toxicity will be reported for each treatment group. Maximum tolerated dose may be determined if dose-limiting toxicity is observed.
Interventions
- PROCEDURE lymph node
- BIOLOGICAL X-ACT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-03-17 |
| Est. Completion | 2016-07-18 |
| Phase | Phase 1 |
Why NCT02327390 stopped before completion
NCT02327390 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 2 interventions - of which lymph node is the first listed.
NCT02327390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02327390 about?
NCT02327390 is a clinical study titled "Ex Vivo-Activated Lymph Node Lymphocytes in Treating Patients With Stage IIIC-IV Melanoma". This phase I trial studies the safety and best dose of ex-vivo activated lymph node lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's lymph node(s) close to a melanoma t...
What is the current status of trial NCT02327390?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2015-03-17. Estimated completion is 2016-07-18.
What interventions are being tested in trial NCT02327390?
The interventions under investigation include: lymph node (PROCEDURE), X-ACT (BIOLOGICAL).
Who is sponsoring clinical trial NCT02327390?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02327390'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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