Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
| Status: | Archived |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune
response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in
different ways to stop tumor cells from dividing so they stop growing or die. Interferon
alfa may interfere with the growth of tumor cells. Combining vaccine therapy with
cyclophosphamide and interferon alfa may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with
interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.
OBJECTIVES:
- Determine the safety, tolerability, and feasibility of vaccine therapy comprising an
allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene
combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with
stage IV breast cancer or other solid tumors.
- Determine the clinical response, time to progression, and survival of patients treated
with this regimen.
- Correlate clinical response with immunological response in patients treated with this
regimen.
OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor
vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic
(non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally
(ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96
hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then
monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
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