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NCT01834248 · ClinicalTrials.gov registry record · Phase 1
DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01834248 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 9 participants.
The verdict
NCT01834248, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205-NY-ESO-1 fusion protein, called CDX-1401, is a full length NY-ESO-1 protein sequence fused to a monoclonal antibody against DEC-205, a surface marker present on many immune stimulatory cells. This drug is given with another substance called PolyICLC, which acts to provoke any immune stimulatory cells which encounter the NY-ESO-1-DEC-205 fusion protein to produce an immune response signal against NY-ESO-1. Immune cells which have thus been primed to react against NY-ESO-1 may then attack myelodysplastic or leukemic cells which express NY-ESO-1 after exposure to the drug decitabine. The chemotherapy drug decitabine is thought to act in several different ways, first, it may directly kill cancer cells, and secondly, the drug can cause cancer cells to re-express genes that are turned off by the cancer, including the gene for NY-ESO-1. Giving DEC-205/NY-ESO-1 fusion protein (CDX-1401) and polyICLC together with decitabine may allow the immune system to more effectively recognize cancer cells and kill them.
Interventions
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Poly ICLC
- BIOLOGICAL DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-07-30 |
| Est. Completion | 2016-03-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01834248
The ClinicalTrials.gov registry entry for NCT01834248 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Decitabine is the first listed.
NCT01834248 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01834248 about?
NCT01834248 is a clinical study titled "DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia". This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205-NY-ESO-1 fusion protein, called CDX-1401, is a full length NY-ESO-1 protein sequence fused to a mono...
What is the current status of trial NCT01834248?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-07-30. Estimated completion is 2016-03-21.
What interventions are being tested in trial NCT01834248?
The interventions under investigation include: Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Poly ICLC (DRUG), DEC-205/NY-ESO-1 Fusion Protein CDX-1401 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01834248?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
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