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.
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
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® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
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® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
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® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
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
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
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
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