NCT00031278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2001

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

February 28, 2002

Last Update Submit

May 26, 2011

Conditions

Carcinoma, Metastatic Breast

Keywords

MetastaticBreastCancerimmunotherapyCPG 7909

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

0.01 mg/kg CPG 7909 plus Herceptin®

Drug: CPG 7909Drug: Herceptin®

Cohort 2

EXPERIMENTAL

0.04 mg/kg CPG 7909 plus Herceptin®

Drug: CPG 7909Drug: Herceptin®

Cohort 3

EXPERIMENTAL

0.16 mg/kg CPG 7909 plus Herceptin®

Drug: CPG 7909Drug: Herceptin®

Cohort 4

EXPERIMENTAL

0.32 mg/kg CPG 7909 plus Herceptin®

Drug: CPG 7909Drug: Herceptin®

Interventions

CPG 7909DRUG

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.

Also known as: PF-3512676, ProMune
Cohort 1
Herceptin®DRUG

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

Also known as: trastuzumab
Cohort 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Univ. of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Cancer Research Network, Inc.

Plantation, Florida, 33324, United States

Location

Greenebaum Cancer Center at Univ. of Maryland

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Comprehensive Cancer Center, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Cancer Center at Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.

Pittsburgh, Pennsylvania, 15213, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

CarcinomaNeoplasm MetastasisNeoplasms

Interventions

ProMuneTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Harold Burstein, M.D., Ph.D.

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 28, 2002

First Posted

March 1, 2002

Study Start

October 1, 2001

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(8)