Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
Public ClinicalTrials.gov record NCT01875653. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01875653
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4 participants
Conditions and interventions
Conditions
Interventions
- Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) Biological
- Autologous PBMCs in GM-CSF (MC) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2014
- Primary completion
- Dec 31, 2015
- Completion
- Dec 31, 2015
- Last update posted
- May 9, 2019
2014 – 2016
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Irvine | California | 92612 | — |
| Not listed | La Jolla | California | 92093 | — |
| Not listed | Los Angeles | California | 90033 | — |
| Not listed | Newport Beach | California | 92625 | — |
| Not listed | Orange | California | 92868 | — |
| Not listed | Santa Monica | California | 90404 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Goshen | Indiana | 46526 | — |
| Not listed | Louisville | Kentucky | 40506 | — |
| Not listed | Marrero | Louisiana | 70072 | — |
| Not listed | Baltimore | Maryland | 21237 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Easton | Pennsylvania | 18020 | — |
| Not listed | Philadelphia | Pennsylvania | 19107 | — |
| Not listed | Philadelphia | Pennsylvania | 19111 | — |
| Not listed | Knoxville | Tennessee | 37996 | — |
| Not listed | Dallas | Texas | 75251 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01875653, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01875653 live on ClinicalTrials.gov.