S0348: A Phase II Study of 5T4-Modified Vaccinia Ankara (MVA) Vaccine (TROVAX) in Patients With Advanced Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
S0348: A Phase II Study of 5T4-Modified Vaccinia Ankara (MVA) Vaccine (TROVAX) in Patients With Advanced Breast Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Stage IIIB-IV disease
- Patients with stage IV disease must have metastasis to the bone only AND
documentation of negative or improved bone scan showing evidence of
recalcification by plain film x-ray OR MRI showing normalization of marrow
signal
- In remission (no evidence of disease)
- Must have completed appropriate treatment (e.g., radiotherapy and chemotherapy)
for primary disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Not specified
Menopausal status
- Not specified
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- No known history of hepatitis B or C
Renal
- Not specified
Immunologic
- No known HIV positivity
- No known history of immune-deficiency disorder
- No history of allergic reaction to prior vaccinia vaccinations
- No autoimmune disease requiring concurrent treatment
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent trastuzumab (Herceptin®) allowed provided it is not part of treatment on
another clinical trial
Chemotherapy
- See Disease Characteristics
- At least 28 days since prior cytotoxic chemotherapy
Endocrine therapy
- At least 28 days since prior steroid therapy
- Concurrent hormonal therapy allowed provided it is not part of treatment on another
clinical trial
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy
Surgery
- Not specified
Other
- At least 28 days since prior and no concurrent treatment on another clinical trial
- Patients enrolled in a SWOG phase III metastatic trial (e.g.,SWOG-S0226 or
SWOG-S0347) who have achieved complete remission but not yet progressed are not
eligible
- Patients enrolled in a SWOG phase II metastatic trial or phase II/III adjuvant
or neoadjuvant trial (e.g., SWOG-S0012, SWOG-S0215, SWOG-S0221, SWOG-S0338, or
SWOG-S0430) who have achieved complete remission/no evidence of disease status
and are no longer receiving study treatment are eligible
- Concurrent bisphosphonates allowed provided it is not part of treatment on another
clinical trial
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Lupe G. Salazar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Tumor Vaccine Group at the University of Washington
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000441167
NCT ID:
NCT00227474
Start Date:
Completion Date:
Related Keywords:
- Breast Cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- Breast Neoplasms
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