MedTrace Logo

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

NCT00031278 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-05-30

No results posted yet for this study

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.

Conditions

  • Carcinoma, Metastatic Breast

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

Sponsors & Collaborators

Principal Investigators

  • Harold Burstein, M.D., Ph.D. · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2003-06-30
Completion
2003-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00031278 on ClinicalTrials.gov