To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
dacarbazine 850mg/m2 in three-week cycles until disease progression
Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
Time frame: indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
Time frame: Indeterminate
Phase III: Assess the overall response rate
Time frame: indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
Time frame: indeterminate
Determine the duration of response.
Time frame: indeterminate
Determine the time to progression
Time frame: indeterminate
Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).
Time frame: indeterminate
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone
Time frame: indeterminate
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CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.