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NCT00911560 · ClinicalTrials.gov registry record · Phase 1
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma
A Phase 1 study of Neuroblastoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 374
- Enrollment target
- 1
- Study location
NCT00911560 is a Phase 1 study of Neuroblastoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 374 participants, above the 235-participant average among 94 other Neuroblastoma trials with a reported enrollment target (59% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00911560, a Phase 1 study of Neuroblastoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 374 participants
- Enrollment target
- 1
- Study location
Study Summary
In the first part of this study we found the highest dose of the vaccine that did not have too many side effects. We are now trying to find out what effects the vaccine has when given at the same dose to all patients. The main treatment in this protocol is a vaccine. It is called a " bivalent vaccine" which means it has 2 antigens. An antigen is a specific protein on the surface of a cell. The antigens are called GD2L and GD3L. We want the vaccine to cause the patient's immune system to make antibodies against the antigens. Antibodies are made by the body to attack cancer (and to fight infections). If the patient can make antibodies against the 2 antigens in the vaccine, those antibodies might also attach to neuroblastoma cells because a lot of each antigen is on neuroblastoma (and very little on other parts of the body). Then, the attached antibodies would attract the patient's white blood cells to kill the neuroblastoma. This protocol also uses β-glucan which is a kind of sugar from yeast. β-glucan is taken by mouth and can help white blood cells kill cancer. The best way to get the body to make antibodies against the 2 antigens is to link each antigen to a protein called KLH (which stands for: keyhole limpet hemocyanin) and to mix them with a substance called QS-21. But it is hard to get enough QS-21 so we are using an identical substance called OPT-821, which we can get easily in large amounts for use in patients.
Conditions Studied
Interventions
- BIOLOGICAL adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH
- BIOLOGICAL oral β-glucan
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2009-05-27 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00911560
The ClinicalTrials.gov registry entry for NCT00911560 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 374 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 235-participant average among 94 other Neuroblastoma trials with a reported enrollment target (59% higher). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 2 interventions - of which adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH is the first listed.
NCT00911560 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00911560 about?
NCT00911560 is a clinical study titled "Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma". In the first part of this study we found the highest dose of the vaccine that did not have too many side effects. We are now trying to find out what effects the vaccine has when given at the same dose to all patients. The main treatment in this protocol is a vaccine. It is called a " bivalent vaccin...
What is the current status of trial NCT00911560?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 374 participants. The study started on 2009-05-27. Estimated completion is 2026-05.
What conditions does trial NCT00911560 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00911560?
The interventions under investigation include: adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH (BIOLOGICAL), oral β-glucan (BIOLOGICAL).
Who is sponsoring clinical trial NCT00911560?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00911560 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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