S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission
NCT ID: NCT00227474
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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recombinant modified vaccinia Ankara-5T4 vaccine
adjuvant therapy
recombinant viral vaccine therapy
Eligibility Criteria
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Inclusion Criteria
* Concurrent bisphosphonates allowed provided it is not part of treatment on another clinical trial
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Principal Investigators
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Lupe G. Salazar, MD
Role: STUDY_CHAIR
Tumor Vaccine Group at the University of Washington
Mary (Nora) L. Disis, MD
Role: STUDY_CHAIR
University of Washington
Other Identifiers
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S0348
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000441167
Identifier Type: -
Identifier Source: org_study_id
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