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NCT00052351 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
NCT00052351: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00052351 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00052351, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study Summary
RATIONALE: Vaccines made from a gene-modified virus may make the body build an 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells. PURPOSE: Randomized clinical trial to study the effectiveness of vaccine therapy plus sargramostim and combination chemotherapy in treating women who have undergone surgery for stage II or stage III breast cancer that has spread to the lymph nodes.
Interventions
- DRUG cyclophosphamide
- DRUG doxorubicin hydrochloride
- BIOLOGICAL sargramostim
- BIOLOGICAL recombinant fowlpox-CEA(6D)/TRICOM vaccine
- BIOLOGICAL recombinant vaccinia-CEA(6D)-TRICOM vaccine
Trial Details
| Field | Value |
|---|---|
| Start Date | 2002-09 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
What the finished NCT00052351 record still lists
NCT00052351 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00052351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00052351 about?
NCT00052351 is a clinical study titled "Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer". RATIONALE: Vaccines made from a gene-modified virus may make the body build an 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. Drugs used in chemotherapy use different ways to stop ...
What is the current status of trial NCT00052351?
This trial is currently completed. It is a Phase 2 study. The study started on 2002-09. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00052351?
The interventions under investigation include: cyclophosphamide (DRUG), doxorubicin hydrochloride (DRUG), sargramostim (BIOLOGICAL), recombinant fowlpox-CEA(6D)/TRICOM vaccine (BIOLOGICAL), recombinant vaccinia-CEA(6D)-TRICOM vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00052351?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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