Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2003

Detailed Description

Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

Interventions

  • Drug: 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.
  • Drug: Herceptin®
    • Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
  • Drug: 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.
  • Drug: Herceptin®
    • Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
  • Drug: 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.
  • Drug: Herceptin®
    • Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
  • Drug: 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.
  • Drug: Herceptin®
    • Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

Arms, Groups and Cohorts

  • Experimental: Cohort 1
    • 0.01 mg/kg CPG 7909 plus Herceptin®
  • Experimental: Cohort 2
    • 0.04 mg/kg CPG 7909 plus Herceptin®
  • Experimental: Cohort 3
    • 0.16 mg/kg CPG 7909 plus Herceptin®
  • Experimental: Cohort 4
    • 0.32 mg/kg CPG 7909 plus Herceptin®

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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%.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Harold Burstein, M.D., Ph.D., Principal Investigator, Dana-Farber Cancer Institute

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