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NCT00179309 · ClinicalTrials.gov registry record · Phase 2
Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT00179309: Completed Phase 2 study of Breast Cancer, sponsored by National Cancer Institute (NCI).
NCT00179309 is a Phase 2 study of Breast Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00179309, a Phase 2 study of Breast Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will test whether giving a combination of a vaccine together with docetaxel is more effective against breast cancer than docetaxel alone. The Food and Drug Administration has approved docetaxel to treat many cancers, including breast cancer. The vaccine consists of three parts: 1) a "priming vaccine" called PANVAC (PAN (all) VAC (vaccine)) trademark \[TM\]-V, which is made from vaccinia virus; 2) a "boosting vaccine" called PANVAC\[TM\]-F, made from fowlpox virus; and 3) sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF), a protein that may help boost the immune system. Human genes are inserted into the vaccinia and fowlpox viruses to cause production of carcinoembryonic antigen (CEA) and mucin 1 (MUC-1)-two proteins that are often produced by cancer cells and can be used as a target for the immune system to attack the cancer. Another type of deoxyribonucleic acid (DNA) is inserted to cause production of other proteins that enhance immune activity. Patients 18 years of age or older with metastatic breast cancer (disease that has spread beyond the original site) and whose cancer produces CEA or mucin 1 (MUC-1) protein may be eligible for this study. Patients must have antigen type human leukocyte antigen A2 (HLA-A2). They may have received adjuvant docetaxel treatment at least 3 months before entering this study, prior hormonal therapy and up to three chemotherapy regimens. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, and computerized tomography (CT) or magnetic resonance imaging scans. Participants are randomly assigned to one of two treatment groups - docetaxel alone or docetaxel plus vaccine - as follows: Docetaxel Alone All patients receive docetaxel. The drug is infused through a vein over 30 to 60 minutes once a week for 3 consecutive weeks with 1 week off drug. Patients also take dexamethasone 12 hours and 1 hour before and 12 hours after the docetaxel
Conditions Studied
Interventions
- DRUG Docetaxel
- BIOLOGICAL Sargramostim
- BIOLOGICAL PANVAC-V
- BIOLOGICAL PANVAC-F
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Texas
- U.T.M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2005-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00179309
The ClinicalTrials.gov registry entry for NCT00179309 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.
NCT00179309 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT00179309 about?
NCT00179309 is a clinical study titled "Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer". This study will test whether giving a combination of a vaccine together with docetaxel is more effective against breast cancer than docetaxel alone. The Food and Drug Administration has approved docetaxel to treat many cancers, including breast cancer. The vaccine consists of three parts: 1) a "prim...
What is the current status of trial NCT00179309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2005-09. Estimated completion is 2013-10.
What conditions does trial NCT00179309 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00179309?
The interventions under investigation include: Docetaxel (DRUG), Sargramostim (BIOLOGICAL), PANVAC-V (BIOLOGICAL), PANVAC-F (BIOLOGICAL).
Who is sponsoring clinical trial NCT00179309?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00179309 being conducted?
This trial has 2 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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