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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Safety, tolerability, and feasibility
Yes
Charles L. Wiseman, MD, FACP
Study Chair
United States: Federal Government
CDR0000393552
NCT00095862
November 2004
Name | Location |
---|---|
Glendale Memorial Hospital Comprehensive Cancer Center | Glendale, California 91204 |
Fountain Valley, California 92708 | |
Hollywood Presbyterian Medical Center | Los Angeles, California 90027-0902 |