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

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Univ. of Connecticut Health Center
    • Florida
      • Plantation, Florida, United States, 33324
        • Cancer Research Network, Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at Univ. of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Comprehensive Cancer Center, University of Michigan
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Cancer Center at Saint Barnabas Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
    • Vermont
      • 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®
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.
Other Names:
  • PF-3512676, ProMune
Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
  • trastuzumab
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
EXPERIMENTAL: Cohort 2
0.04 mg/kg CPG 7909 plus Herceptin®
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.
Other Names:
  • PF-3512676, ProMune
Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
  • trastuzumab
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
EXPERIMENTAL: Cohort 3
0.16 mg/kg CPG 7909 plus Herceptin®
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.
Other Names:
  • PF-3512676, ProMune
Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
  • trastuzumab
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
EXPERIMENTAL: Cohort 4
0.32 mg/kg CPG 7909 plus Herceptin®
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.
Other Names:
  • PF-3512676, ProMune
Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Names:
  • trastuzumab
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune
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.
Other Names:
  • PF-3512676, ProMune

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

Pfizer

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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