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NCT00048893 · ClinicalTrials.gov registry record · Phase 1
Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT00048893: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00048893 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048893, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface. Patients who require surgery or radiation therapy, or both, will receive these treatments as well. Patients 18 years of age and older with previously untreated metastatic breast cancer may be eligible for this study. Newly diagnosed patients may not have received prior chemotherapy. Patients previously diagnosed with local disease may have received chemotherapy or radiation therapy at least 18 months before entering the current study. Patients may have received hormonal therapy for stage IV disease. Candidates are screened with a medical history and physical examination, blood and urine tests, x-rays, heart and lung tests, and a test to determine the presence of CEA on their tumor cells. Participants undergo the following procedures: 1. Central venous line: Under local or general anesthesia, an intravenous catheter (plastic tube) is inserted into a major vein in the chest. It is used to give chemotherapy and other medications and to withdraw blood samples. 2. Apheresis: Before beginning treatment and at various times before and after chemotherapy, patients undergo apheresis to collect white blood cells for later re-infusion at the time of immunizations and to evaluate the body's response to the vaccines. For this procedure, blood is collected through the central venous catheter and circulated through a machine that separates the white cells from the rest of the blood. The white cells are removed and frozen for later use. The rest of the blood is returned to the patient through the catheter. 3. First vaccine: Before starting chemotherapy, patients receive one subcutaneous (under the skin) injection of a vaccine called rV-CEA-Tricom, along with subcutaneous injections of granulocyte macrophage c
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL filgrastim
- BIOLOGICAL sargramostim
- BIOLOGICAL recombinant fowlpox-CEA(6D)/TRICOM vaccine
- BIOLOGICAL recombinant vaccinia-CEA(6D)/TRICOM vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2002-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048893
The ClinicalTrials.gov registry entry for NCT00048893 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 37 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 5 interventions - of which cyclophosphamide is the first listed.
NCT00048893 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048893 about?
NCT00048893 is a clinical study titled "Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer". This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface. Patients who require surg...
What is the current status of trial NCT00048893?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2002-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00048893?
The interventions under investigation include: cyclophosphamide (DRUG), filgrastim (BIOLOGICAL), sargramostim (BIOLOGICAL), recombinant fowlpox-CEA(6D)/TRICOM vaccine (BIOLOGICAL), recombinant vaccinia-CEA(6D)/TRICOM vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00048893?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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