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NCT00009958 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy With or Without Sargramostim in Treating Patients With Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00009958: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00009958 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00009958, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Phase I trial to compare the effectiveness of vaccine therapy with or without sargramostim in treating patients who have solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines may kill more tumor cells.
Primary Outcome
Pre and post-vaccination CTL precursor frequencies will be calculated so that changes in CTL precursor frequencies can be compared between dose levels of the vaccine. Also, 95% confidence intervals can be calculated for the percent increases (or decreases) in CTL precursor frequencies between dose levels.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL sargramostim
- BIOLOGICAL recombinant fowlpox-CEA(6D)/TRICOM vaccine
- BIOLOGICAL recombinant vaccinia-CEA(6D)-TRICOM vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2000-11 |
| Phase | Phase 1 |
Why NCT00009958 stopped before completion
NCT00009958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00009958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00009958 about?
NCT00009958 is a clinical study titled "Vaccine Therapy With or Without Sargramostim in Treating Patients With Cancer". Phase I trial to compare the effectiveness of vaccine therapy with or without sargramostim in treating patients who have solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines may kill more tumor ...
What is the current status of trial NCT00009958?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2000-11.
What interventions are being tested in trial NCT00009958?
The interventions under investigation include: laboratory biomarker analysis (OTHER), sargramostim (BIOLOGICAL), recombinant fowlpox-CEA(6D)/TRICOM vaccine (BIOLOGICAL), recombinant vaccinia-CEA(6D)-TRICOM vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00009958?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00009958's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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