S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission.
|Breast Cancer||Drug: recombinant modified vaccinia Ankara-5T4 vaccine Procedure: adjuvant therapy Procedure: recombinant viral vaccine therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||S0348: A Phase II Study of 5T4-Modified Vaccinia Ankara (MVA) Vaccine (TROVAX) in Patients With Advanced Breast Cancer|
- Determine the feasibility of conducting a live viral vaccine trial using adjuvant recombinant modified vaccinia Ankara-5T4 vaccine (TroVax®) in patients with stage IIIB-IV breast cancer in remission.
- Determine the progression-free survival of patients treated with this vaccine.
- Determine the 5T4-specific T-cell immune response in patients treated with this vaccine.
- Determine the toxicity of this vaccine in these patients.
- Determine the level of 5T4-specific antibody response in patients treated with this vaccine.
- Correlate, preliminarily, immune response with 3- and 12-month progression-free survival of patients treated with this vaccine.
- Correlate tumor 5T4 expression with overall survival and progression-free survival of patients treated with this vaccine.
- Correlate tumor infiltrating lymphocyte and CD1a-positive dendritic cell density with development of 5T4-specific T-cell immunity in patients treated with this vaccine.
OUTLINE: This is a multicenter study.
Patients receive recombinant modified vaccinia Ankara-5T4 vaccine (TroVax®) intramuscularly once a month in months 1-3. Patients then receive booster vaccinations once in months 6, 9, and 12. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227474
|Study Chair:||Lupe G. Salazar, MD||Tumor Vaccine Group at the University of Washington|
|Study Chair:||Mary (Nora) L. Disis, MD||University of Washington|