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NCT00924092 · ClinicalTrials.gov registry record · Phase 1
An Open Label Phase I Study to Eval the Safety and Tolerability of a Vaccine (GI-6207) Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-expressing ...
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00924092: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00924092 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924092, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Objectives: * To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects. * To see if GI-6207 has any effect on patients tumors. * To learn how the vaccine causes immune responses against the cancer. Eligibility: * Patients 18 years of age and older who have been diagnosed with a cancer that has not responded to standard treatments. Patients must not be allergic to yeast or yeast products. Design: * Initial physical examination, blood and tissue sampling, computed tomography (CT) scan, and skin test to determine eligibility for the procedure. * Treatment with GI-6027 in seven 14-day cycles as follows: * Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85. * Vaccine given at four sites around the body: right and left chest area below the armpit, and right and left upper thigh in the pelvic region. (These areas drain into parts of your body that contain large numbers of lymph nodes. The lymph nodes contain immune cells that may be activated by the vaccine to target cancer cells.) * Clinic visits for physical examinations to check vital signs, take additional blood and urine samples, and perform other tests needed for the study. * After day 85 (about 3 months), patients will continue to receive vaccine monthly (or every 28 days) as long as the vaccine is not producing harmful effects or side effects and the cancer is either stable or reducing. Patients who do well on the vaccine may continue to receive it for as long as it is available.
Interventions
- BIOLOGICAL GI-6207 [Recombinant Saccharomyces Cerevisia
- DRUG (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)])
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-03-13 |
| Est. Completion | 2012-08-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00924092
The ClinicalTrials.gov registry entry for NCT00924092 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GI-6207 [Recombinant Saccharomyces Cerevisia is the first listed.
NCT00924092 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00924092 about?
NCT00924092 is a clinical study titled "An Open Label Phase I Study to Eval the Safety and Tolerability of a Vaccine (GI-6207) Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-expressing ...". Objectives: * To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects. * To see if GI-6207 has any effect on patients tumors. * To learn how the vaccine causes immune responses against the cance...
What is the current status of trial NCT00924092?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2009-03-13. Estimated completion is 2012-08-02.
What interventions are being tested in trial NCT00924092?
The interventions under investigation include: GI-6207 [Recombinant Saccharomyces Cerevisia (BIOLOGICAL), (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)]) (DRUG).
Who is sponsoring clinical trial NCT00924092?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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