drugset / Trial / NCT00031278
Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2001-10
- Primary completion
- 2003-06
- Completion
- 2003-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | agatolimod | Oligonucleotide (other) | 0.01 mg/kg | — |
| Subject | agatolimod | Oligonucleotide (other) | 0.04 mg/kg | — |
| Subject | agatolimod | Oligonucleotide (other) | 0.16 mg/kg | — |
| Subject | agatolimod | Oligonucleotide (other) | 0.32 mg/kg | — |