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NCT00669734 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery
A Phase 1 study of Pancreatic Ductal Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00669734: Active Phase 1 study of Pancreatic Ductal Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT00669734 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00669734, a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy directly into the tumor together with sargramostim may cause a stronger immune response and kill more tumor cells.
Primary Outcome
The descriptions and grading scales found in the Cancer Therapy Evaluation Program (CTEP) Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for adverse events (AE) reporting.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Sargramostim
- BIOLOGICAL Falimarev
- BIOLOGICAL Inalimarev
Study Locations (1)
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-02-01 |
| Est. Completion | 2026-04-23 |
| Phase | Phase 1 |
What the registry record for NCT00669734 still lists
NCT00669734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00669734 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT00669734 about?
NCT00669734 is a clinical study titled "Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery". This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effecti...
What is the current status of trial NCT00669734?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-02-01. Estimated completion is 2026-04-23.
What conditions does trial NCT00669734 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage III Pancreatic Cancer AJCC v6 and v7, Pancreatic Acinar Cell Carcinoma.
What interventions are being tested in trial NCT00669734?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), Falimarev (BIOLOGICAL), Inalimarev (BIOLOGICAL).
Who is sponsoring clinical trial NCT00669734?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00669734 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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