Status:
COMPLETED
Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With 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: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and trastuzumab, may in...
Detailed Description
OBJECTIVES: Primary * To evaluate the safety of cyclophosphamide-modulated vaccination with vs without trastuzumab in patients with breast cancer that does not overexpress HER-2/neu. * To compare th...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC
- Stage IV disease
- Must not be eligible for therapy of known curative potential for metastatic breast cancer
- Measurable or evaluable disease
- Stable CNS disease allowed provided that it's adequately treated and 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
- Platelets \> 100,000/mm\^3
- Serum bilirubin \< 2.0 mg/dL (unless due to Gilbert syndrome)
- AST and ALT \< 2 times upper limit of normal (ULN)
- Alkaline phosphatase \< 5 times ULN
- Serum creatinine \< 2.0 mg/dL
- Ejection fraction normal by MUGA OR ≥ 50% by echocardiogram
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed
- No prior or concurrent 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
- Sjogren syndrome
- Sarcoidosis
- Other rheumatologic disease
- No other malignancies within the past 5 years, except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related endometrial cancer that has been adequately treated
- No active major medical or psychosocial problems that could be complicated by study participation
- No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
- No uncontrolled medical problems
- No evidence of active acute or chronic infection
- No known severe hypersensitivity to trastuzumab, except mild to moderate infusion reactions that are easily managed and do not recur
- No allergy to corn
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior and no other concurrent chemotherapy, radiation therapy, or biologic therapy (except trastuzumab)
- Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed
- More than 28 days since prior and no other concurrent participation in an investigational new drug trial
- More than 28 days since prior and no other concurrent systemic oral steroids
- Topical, ocular, and nasal steroids allowed
- No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00971737
Start Date
July 1 2009
End Date
March 1 2016
Last Update
April 24 2019
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