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NCT00299728 · ClinicalTrials.gov registry record · Phase 1
NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
A Phase 1 study of Tumors, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT00299728: Completed Phase 1 study of Tumors, sponsored by Ludwig Institute for Cancer Research.
NCT00299728 is a Phase 1 study of Tumors that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 22 participants, below the 198-participant average among 20 other Tumors trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299728, a Phase 1 study of Tumors, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1. The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses. Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible, regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry. The primary objective of the study was to define safety. Secondarily, the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein. Blood samples were to be obtained at baseline, prior to each vaccination, one week after each vaccination, and at the last study visit for the assessment of NY-ESO-1-specific CD4+ and CD8+ T cells. Cytokine secretion by NY-ESO-1-specific CD8+ and CD4+ T cells, as a measure of T cell activation, was to be determined by FACS analysis. In addition, humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA. Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable (measurable and non-measurable) disease.
Primary Outcome
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0). DLT was defined as ≥ Grade 3 hematological and non-hematological toxicities or ≥ Grade 2 allergic reaction for generalized urticaria that wa
Conditions Studied
Interventions
- BIOLOGICAL NY-ESO-1 Protein Vaccine
Study Locations (2)
New York
- NYU Clinical Cancer Center - New York
- NY Presbyterian- Columbia - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2006-03-21 |
| Est. Completion | 2014-01-10 |
| Phase | Phase 1 |
What the finished NCT00299728 record still lists
NCT00299728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 198-participant average among 20 other Tumors trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Tumors appearing as the primary indexed condition, and to 1 intervention - of which NY-ESO-1 Protein Vaccine is the first listed.
NCT00299728 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00299728 about?
NCT00299728 is a clinical study titled "NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors". This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1. The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses. Patients with any malignancy that is kno...
What is the current status of trial NCT00299728?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2006-03-21. Estimated completion is 2014-01-10.
What conditions does trial NCT00299728 study?
This clinical trial studies the following conditions: Tumors.
What interventions are being tested in trial NCT00299728?
The interventions under investigation include: NY-ESO-1 Protein Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00299728?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00299728 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00299728's enrollment target sits among peer trials
22 19th of 20 higher than 2 of 20 other Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tumors 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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