Clinical trial NCT00031278: Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Metastatic Breast
Keywords: Metastatic
Breast
Cancer
immunotherapy
CPG 7909
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-03-01
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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%.

Primary outcomes:
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
measure: Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer
Secondary outcomes:
measure: Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
measure: Phase II: To evaluate duration of response, time to disease progression, and survival time
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Univ. of Connecticut Health Center
state: Connecticut
city: Plantation
country: United States
facility: Cancer Research Network, Inc.
state: Florida
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at Univ. of Maryland
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: Comprehensive Cancer Center, University of Michigan
state: Michigan
city: Livingston
country: United States
facility: Cancer Center at Saint Barnabas Medical Center
state: New Jersey
city: Pittsburgh
country: United States
facility: Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
state: Pennsylvania
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Harold Burstein, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: