Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
May 26, 2011 updated by: Pfizer
A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer
The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- Univ. of Connecticut Health Center
-
-
Florida
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Plantation, Florida, United States, 33324
- Cancer Research Network, Inc.
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at Univ. of Maryland
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Comprehensive Cancer Center, University of Michigan
-
-
New Jersey
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Livingston, New Jersey, United States, 07039
- Cancer Center at Saint Barnabas Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
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Vermont
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
INCLUSION CRITERIA Inclusion Criteria
- Histologically confirmed breast cancer with metastases.
- 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
- Any prior therapy with anthracycline + Herceptin®.
- 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%.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Cohort 1
0.01 mg/kg CPG 7909 plus Herceptin®
|
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.
Other Names:
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Cohort 2
0.04 mg/kg CPG 7909 plus Herceptin®
|
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.
Other Names:
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Cohort 3
0.16 mg/kg CPG 7909 plus Herceptin®
|
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.
Other Names:
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Cohort 4
0.32 mg/kg CPG 7909 plus Herceptin®
|
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.
Other Names:
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer
|
|
Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
|
|
Phase II: To evaluate duration of response, time to disease progression, and survival time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harold Burstein, M.D., Ph.D., Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (ACTUAL)
June 1, 2003
Study Completion (ACTUAL)
June 1, 2003
Study Registration Dates
First Submitted
February 28, 2002
First Submitted That Met QC Criteria
February 28, 2002
First Posted (ESTIMATE)
March 1, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
May 30, 2011
Last Update Submitted That Met QC Criteria
May 26, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C005
- A8501020
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