Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
NCT ID: NCT00031278
Last Updated: 2011-05-30
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
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2001-10-31
2003-06-30
Brief Summary
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RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.
SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.
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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
0.01 mg/kg CPG 7909 plus Herceptin®
CPG 7909
Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Cohort 2
0.04 mg/kg CPG 7909 plus Herceptin®
CPG 7909
Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Cohort 3
0.16 mg/kg CPG 7909 plus Herceptin®
CPG 7909
Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Cohort 4
0.32 mg/kg CPG 7909 plus Herceptin®
CPG 7909
Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Interventions
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CPG 7909
Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
CPG 7909
Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
CPG 7909
Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
CPG 7909
Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
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 must be candidates for single agent Herceptin treatment according to the Herceptin® label.
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%.
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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Harold Burstein, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Univ. of Connecticut Health Center
Farmington, Connecticut, United States
Cancer Research Network, Inc.
Plantation, Florida, United States
Greenebaum Cancer Center at Univ. of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Comprehensive Cancer Center, University of Michigan
Ann Arbor, Michigan, United States
Cancer Center at Saint Barnabas Medical Center
Livingston, New Jersey, United States
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
Pittsburgh, Pennsylvania, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Countries
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Other Identifiers
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C005
Identifier Type: -
Identifier Source: secondary_id
A8501020
Identifier Type: -
Identifier Source: secondary_id
C005
Identifier Type: -
Identifier Source: org_study_id
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