Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
- Registration Number
- NCT00031278
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 Herceptin® 0.01 mg/kg CPG 7909 plus Herceptin® Cohort 2 Herceptin® 0.04 mg/kg CPG 7909 plus Herceptin® Cohort 3 Herceptin® 0.16 mg/kg CPG 7909 plus Herceptin® Cohort 1 CPG 7909 0.01 mg/kg CPG 7909 plus Herceptin® Cohort 2 CPG 7909 0.04 mg/kg CPG 7909 plus Herceptin® Cohort 3 CPG 7909 0.16 mg/kg CPG 7909 plus Herceptin® Cohort 4 CPG 7909 0.32 mg/kg CPG 7909 plus Herceptin® Cohort 4 Herceptin® 0.32 mg/kg CPG 7909 plus Herceptin®
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (8)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Univ. of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Cancer Research Network, Inc.
🇺🇸Plantation, Florida, United States
Comprehensive Cancer Center, University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Greenebaum Cancer Center at Univ. of Maryland
🇺🇸Baltimore, Maryland, United States
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
🇺🇸Pittsburgh, Pennsylvania, United States
Cancer Center at Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States