ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
Sponsor study identifier
Secondary identifiers
interventional
184
0 countries
N/A
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2005
Actual (reported)Study Completion
December 2005
Actual (reported)To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2003
Actual (reported)October 8, 2003
Actual (reported)December 2003
Date type not reportedThis date has not been verified as actual or estimated.
December 2005
Actual (reported)December 2005
Actual (reported)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
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
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
CPG 7909 Injection plus DTIC
dacarbazine
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
Pfizer CT.gov Call Center
Pfizer
184 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2003
First Posted
October 8, 2003
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2005
Actual (reported)Study Completion
December 2005
Actual (reported)Last Updated
February 10, 2009
Record last verified: 2009-02
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Source: ClinicalTrials.gov.
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