Clinical Trial: CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma
Brief Summary: To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome:
- Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs [ Time Frame: 24 weeks ]
- Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA. [ Time Frame: 24 weeks ]
Original Primary Outcome:
Current Secondary Outcome: Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease. [ Time Frame: indeterminate ]
Original Secondary Outcome:
Information By: Pfizer
Dates:
Date Received: August 8, 2002
Date Started: January 2003
Date Completion:
Last Updated: February 11, 2009
Last Verified: February 2009
