Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CO23, A8501023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPG 7909 Injection plus chemotherapy | Experimental | CPG 7909 Injection plus DTIC |
|
| Chemotherapy alone | Active Comparator | dacarbazine |
|
| CPG 7909 Injection 10 mg | Experimental |
| |
| CPG 7909 Injection 40 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPG 7909 Injection | Drug | CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria. | indeterminate | |
| Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II. | Indeterminate |
| Measure | Description | Time Frame |
|---|---|---|
| Phase III: Assess the overall response rate | indeterminate | |
| Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease. | indeterminate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| C483020 | ProMune |
| D003606 | Dacarbazine |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| dacarbazine | Drug | dacarbazine 850mg/m2 in three-week cycles until disease progression |
|
|
| Chemotherapy | Drug | Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2 |
|
|
| CPG 7909 Injection | Drug | CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly. |
|
|
| CPG 7909 Injection | Drug | CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly. |
|
|
| Determine the duration of response. | indeterminate |
| Determine the time to progression | indeterminate |
| Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only). | indeterminate |
| Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone | indeterminate |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |