Breast Cancer Clinical Trial
Official title:
S0348: A Phase II Study of 5T4-Modified Vaccinia Ankara (MVA) Vaccine (TROVAX) in Patients With Advanced Breast Cancer
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.
OBJECTIVES:
- 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.
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Masking: Open Label, Primary Purpose: Treatment
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