Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01875653 · ClinicalTrials.gov registry record · Phase 3
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
A Phase 3 study, sponsored by Lisata Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT01875653 is a Phase 3 study that was terminated before completion, run by Lisata Therapeutics. The registered enrollment target is 4 participants.
The verdict
NCT01875653, a Phase 3 study, was terminated before completion, sponsored by Lisata Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study therapy") because it is not yet approved by the U.S. Food and Drug Administration (FDA). This research study will use the patient's own tumor cells,the patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a standard treatment to help increase the number of white blood cells after chemotherapy. The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the growth factor. The resulting solution is called the study therapy. The intent of the study therapy is to make the dendritic cells more effective at fighting the tumor when they are injected back into the patient.
Interventions
- BIOLOGICAL Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)
- BIOLOGICAL Autologous PBMCs in GM-CSF (MC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01875653
The ClinicalTrials.gov registry entry for NCT01875653 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lisata Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) is the first listed.
NCT01875653 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01875653 about?
NCT01875653 is a clinical study titled "Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma". The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study t...
What is the current status of trial NCT01875653?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2014-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01875653?
The interventions under investigation include: Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) (BIOLOGICAL), Autologous PBMCs in GM-CSF (MC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01875653?
This trial is sponsored by Lisata Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.