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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00031278
Recruitment Status : Completed
First Posted : March 1, 2002
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Carcinoma, Metastatic Breast Drug: CPG 7909 Drug: Herceptin® Phase 1 Phase 2

Detailed Description:
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : October 2001
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 Name: PF-3512676, ProMune

Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Name: trastuzumab
Experimental: Cohort 2
0.04 mg/kg CPG 7909 plus Herceptin®
 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 Name: PF-3512676, ProMune

Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Name: trastuzumab
Experimental: Cohort 3
0.16 mg/kg CPG 7909 plus Herceptin®
 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 Name: PF-3512676, ProMune

Drug: Herceptin®
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Other Name: trastuzumab
Experimental: Cohort 4
0.32 mg/kg CPG 7909 plus Herceptin®
 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 Name: PF-3512676, ProMune

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


Outcome Measures
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Primary Outcome Measures :
  1. 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
  2. Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer

Secondary Outcome Measures :
  1. Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
  2. Phase II: To evaluate duration of response, time to disease progression, and survival time

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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%.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031278


Locations
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United States, Connecticut
Univ. of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324
United States, Maryland
Greenebaum Cancer Center at Univ. of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Comprehensive Cancer Center, University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Cancer Center at Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, Pennsylvania
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
Pittsburgh, Pennsylvania, United States, 15213
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Harold Burstein, M.D., Ph.D. Dana-Farber Cancer Institute
More Information
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00031278    
Other Study ID Numbers: C005
C005
A8501020
First Posted: March 1, 2002    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011
Keywords provided by Pfizer:
Metastatic
Breast
Cancer
immunotherapy
CPG 7909
Additional relevant MeSH terms:
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Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents