Finding studies
Finding studies
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Lead
Wiseman Research Initiatives LLC
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
