Status:
COMPLETED
Vaccine Therapy With or Without Cyclophosphamide and Doxorubicin in Women With Stage IV Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in diffe...
Detailed Description
OBJECTIVES: Primary * Determine the safety of vaccination comprising allogeneic sargramostim (GM-CSF)-secreting breast cancer cells with or without immunomodulation using cyclophosphamide and doxoru...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Stage IV disease
- Stable disease for ≥ 28 days
- Measurable or evaluable disease OR no evidence of disease
- Not eligible for potentially curative therapy
- Adequately treated CNS metastases are allowed
- Hormone receptor status:
- Not specified
- HER-2/neu status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome)
- AST and ALT ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- Renal
- Creatinine \< 2.0 mg/dL
- Cardiovascular
- Ejection fraction ≥ 45% by echocardiogram or MUGA
- Pulmonary
- Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required
- Immunologic
- No active autoimmune disease requiring systemic immunosuppressive therapy, including any of the following:
- Inflammatory bowel disease
- Systemic vasculitis
- Scleroderma
- Psoriasis
- Multiple sclerosis
- Hemolytic anemia
- Immune-mediated thrombocytopenia
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Sjögren's syndrome
- Sarcoidosis
- Other rheumatologic disease
- HIV negative
- No active acute or chronic infection
- No allergy to corn
- Other
- No other malignancy within the past 5 years except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer
- No active major medical or psychosocial problem that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 28 days since prior biologic therapy
- No other concurrent biologic therapy, including trastuzumab (Herceptin®)
- Chemotherapy
- Prior adjuvant chemotherapy allowed
- Prior doxorubicin and cyclophosphamide allowed
- Prior doxorubicin dose combined with planned study therapy dose must not exceed a lifetime cumulative dose of ≥ 450 mg/m\^2
- More than 28 days since prior systemic chemotherapy
- No other concurrent systemic chemotherapy
- Endocrine therapy
- More than 28 days since prior systemic corticosteroids
- Concurrent hormonal or endocrine therapy allowed
- No concurrent systemic corticosteroids
- Radiotherapy
- More than 28 days since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- More than 28 days since prior participation in another investigational drug trial
- No other concurrent investigational drugs
- Concurrent bisphosphonates allowed
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00093834
Start Date
January 1 2004
Last Update
July 3 2023
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410