Status:
WITHDRAWN
S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 preven...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00227474
Last Update
January 24 2013
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