CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
NCT ID: NCT00043394
Last Updated: 2009-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2002-09-30
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
0.04 mg/kg CpG 7909
0.04 mg/kg CpG 7909
0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Cohort 2
0.08 mg/kg CpG 7909
0.08 mg/kg CpG 7909
0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Cohort 3
0.12 mg/kg CpG 7909 Injection once weekly
0.12 mg/kg CpG 7909
0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Cohort 4
0.16 mg/kg CpG 7909
0.16 mg/kg CpG 7909
0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Interventions
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0.04 mg/kg CpG 7909
0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.08 mg/kg CpG 7909
0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.12 mg/kg CpG 7909
0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.16 mg/kg CpG 7909
0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry
* Patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.
* Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques, or as \> 10 mm with spiral CT scan
Exclusion Criteria
* Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction \< 50%
* Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Berkely, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Palm Springs, California, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Plantation, Florida, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Dearborn, Michigan, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
West Bloomfield, Michigan, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Burlington, Vermont, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8501021, CO15
Identifier Type: -
Identifier Source: secondary_id
C015
Identifier Type: -
Identifier Source: org_study_id
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