drugset / Trial / NCT00052351
Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
RandomizedTreatment
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.
Timeline
- Start
- 2002-09
- Primary completion
- —
- Completion
- 2007-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | recombinant fowlpox-CEA(6D)/TRICOM vaccine | Vaccine | — | Subcutaneous |
| Subject | recombinant vaccinia-CEA(6D)-TRICOM vaccine | Vaccine | — | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | — | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |