Status:
COMPLETED
Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * To evaluate the safety of allogeneic sargramostim (GM-CSF)-secreting breast cancer vaccine in combination with trastuzumab (Herceptin®) and cyclophosphamide in patients with hi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast, meeting one of the following criteria:
- Metastatic disease
- High-risk disease, defined as early-stage disease with pathologic involvement of locoregional lymph nodes
- Patients who are/will be receiving standard adjuvant trastuzumab \[Herceptin®\] for high-risk disease will participate in this study during the single-agent trastuzumab portion of their therapy
- No clinical or radiographical evidence of active disease
- Not eligible for therapy of known curative potential for metastatic breast cancer
- HER2/neu-overexpressing disease, defined as HER2/neu positive by IHC 3+ staining or by FISH+ amplification
- Stable CNS disease allowed provided it has been adequately treated and is not under active treatment
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- ANC \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Serum creatinine \< 2.0 mg/dL
- Serum bilirubin ≤ 2.0 mg/dL (unless elevation is due to known Gilbert's syndrome)
- AST/ALT ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Cardiac ejection fraction normal by MUGA OR ≥ 45% by ECHO
- No other malignancies within the past 5 years, except for carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer
- No prior or currently active autoimmune disease\* requiring management with systemic immunosuppression, including any of the following:
- Inflammatory bowel disease
- Systemic vasculitis
- Scleroderma
- Psoriasis
- Multiple sclerosis
- Hemolytic anemia or immune-mediated thrombocytopenia
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Sjögren syndrome
- Sarcoidosis
- Other rheumatologic disease
- No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
- HIV-negative
- No evidence of active acute or chronic infection
- No uncontrolled medical problems
- No active major medical or psychosocial problems that could be complicated by study participation
- No corn allergy
- No known severe hypersensitivity to trastuzumab (except for mild to moderate infusion reactions that are easily managed and do not recur) NOTE: \*Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed
- PRIOR CONCURRENT THERAPY:
- Any number of prior chemotherapy regimens for metastatic breast cancer allowed
- Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed
- More than 28 days since prior and no concurrent systemic oral steroids
- Topical, ocular, or nasal steroids allowed
- More than 28 days since prior and no concurrent chemotherapy, radiotherapy, or biologic therapy (except trastuzumab)
- More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug
- Concurrent endocrine therapy or bisphosphonates allowed
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00847171
Start Date
December 1 2008
End Date
June 1 2013
Last Update
September 26 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410