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| ID | Type | Description | Link |
|---|---|---|---|
| ProMune | |||
| CO17 | |||
| A8501017 |
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Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection |
|
| 2 | Active Comparator | Chemotherapy (a taxane and a platinum compound) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPG 7909 | Drug | CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy- overall response rate (CR & PR) according to the RECIST criteria | Indeterminate | |
| Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations | Indeterminate |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy | Indeterminate | |
| compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups | Indeterminate | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Ronald Yanagihara | Gilroy | California | 95020 | United States | ||
| Kenmar Research Institute, LLC |
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|
| Chemotherapy | Drug | A taxane and a platinum compound given on week one of three-week cycles: Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6 |
|
| Chemotherapy | Drug | A taxane and a platinum compound given on week one of three-week cycles: Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6 |
|
|
| duration of overall response (CR, PR), survival time, and time to disease progression. |
| Indeterminate |
| To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. | Indeterminate |
| Los Angeles |
| California |
| 90057 |
| United States |
| Comprehensive Cancer Center of the Dessert | Palm Springs | California | 92262 | United States |
| Florida Cancer Specialist | Fort Myers | Florida | 33901 | United States |
| Indiana Hematology and Oncology Associates | Indianapolis | Indiana | 46202 | United States |
| Medical Center Vincennes | Vincennes | Indiana | 47591 | United States |
| Kentucky Cancer Clinic | Hazard | Kentucky | 41701 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Southeast Nebraska Hematology Oncology Consultants, PC | Lincoln | Nebraska | 68516 | United States |
| VA New Jersey Health Care System | East Orange | New Jersey | 07018 | United States |
| HemOnCare | Brooklyn | New York | 11212 | United States |
| Cancer Care of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Cancer Care Institute of Carolina | Aiken | South Carolina | 29801 | United States |
| Charleston Hematology/Oncology, PA | Charleston | South Carolina | 29403 | United States |
| The Family Cancer Center | Collierville | Tennessee | 38017 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Queen Elizabeth II Health | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Ottawa Regional Cancer Center | Ottawa | Ontario | K1H 1C4 | Canada |
| McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Staedtisches Krankenhaus Martha-Maria | Halle-Dolau | D-06120 | Germany |
| Universitätsklinikum Mannheim der Universität Heidelberg | Heidelberg | Germany |
| St. Vincentius-Kliniken gAG, Hamatologie-Onkologie | Karlsruhe | D76137 | Germany |
| Klinikum Rechts der Isar | München | 81675 | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C483020 | ProMune |
| D004358 | Drug Therapy |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
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