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| ID | Type | Description | Link |
|---|---|---|---|
| C005 | |||
| A8501020 |
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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.
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.01 mg/kg CPG 7909 plus Herceptin® |
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| Cohort 2 | Experimental | 0.04 mg/kg CPG 7909 plus Herceptin® |
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| Cohort 3 | Experimental | 0.16 mg/kg CPG 7909 plus Herceptin® |
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| Cohort 4 | Experimental | 0.32 mg/kg CPG 7909 plus Herceptin® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPG 7909 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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INCLUSION CRITERIA Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Harold Burstein, M.D., Ph.D. | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of Connecticut Health Center | Farmington | Connecticut | 06030 | United States | ||
| Cancer Research Network, Inc. |
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| Herceptin® | Drug | Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert |
|
|
| CPG 7909 | Drug | 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. |
|
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| Herceptin® | Drug | Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert |
|
|
| CPG 7909 | Drug | 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. |
|
|
| Herceptin® | Drug | Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert |
|
|
| CPG 7909 | Drug | 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. |
|
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| Herceptin® | Drug | Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert |
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| Plantation |
| Florida |
| 33324 |
| United States |
| Greenebaum Cancer Center at Univ. of Maryland | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Comprehensive Cancer Center, University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Cancer Center at Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp. | Pittsburgh | Pennsylvania | 15213 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C483020 | ProMune |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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