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NCT01456104 · ClinicalTrials.gov registry record · Phase 1
Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma
A Phase 1 study of Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01456104: Completed Phase 1 study of Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01456104 is a Phase 1 study of Melanoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 9 participants, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456104, a Phase 1 study of Melanoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to see if the investigators can help the immune system to work against melanoma. A dendritic cell is another type of white blood cell. It has most, if not all, of the proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the antigens with dendritic cells to make a vaccine. The investigators think that the body's T cells might then react against the tumor and help destroy it. This study will see if altered dendritic cells will make T cells work against tumor cells. The dendritic cells will be made in a lab and will carry the antigens. These cells then will be injected under the skin. In this study, the investigators are trying to help the body make a stronger immune response against the cancer. The patient will get the same kind of dendritic cell vaccine used in the earlier study, but with one major difference. The dendritic cells will contain messenger-RNA (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a laboratory method called electroporation. The mRNA is never given to the patient directly. This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses. The dendritic cell can then put this tumor antigen on its surface so that the body could make a stronger immune response against the tumor.
Primary Outcome
Toxicity will be graded according to standard NCI/CTEP toxicity criteria. This protocol will use the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Conditions Studied
Interventions
- BIOLOGICAL Langerhans-type dendritic cells (a.k.a. Langerhans cells or LCs)
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-10-17 |
| Est. Completion | 2023-01-12 |
| Phase | Phase 1 |
What the finished NCT01456104 record still lists
NCT01456104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Langerhans-type dendritic cells (a.k.a. Langerhans cells or LCs) is the first listed.
NCT01456104 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01456104 about?
NCT01456104 is a clinical study titled "Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma". This study is being done to see if the investigators can help the immune system to work against melanoma. A dendritic cell is another type of white blood cell. It has most, if not all, of the proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have...
What is the current status of trial NCT01456104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-10-17. Estimated completion is 2023-01-12.
What conditions does trial NCT01456104 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01456104?
The interventions under investigation include: Langerhans-type dendritic cells (a.k.a. Langerhans cells or LCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01456104?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01456104 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01456104's enrollment target sits among peer trials
9 254th of 266 higher than 13 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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