CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Phase 1

Completed

• Conditions: Lymphoma, T-Cell, Cutaneous
• Interventions: Drug: PF-3512676

• Registration Number: NCT00043420
• Lead Sponsor: Pfizer

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 Description

Not available

Study Timeline

• Study First Submitted: 2002-08-08
• Study First Submitted QC: 2002-08-09
• Study First Posted: 2002-08-12
• Study Start: 2003-01
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments.

Exclusion Criteria

Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I: 0.16 mg/kg	PF-3512676	Escalating dose groups: 0.16 mg/kg PF-3512676 Injection
Phase I: 0.32 mg/kg	PF-3512676	Escalating dose groups: 0.32 mg/kg PF-3512676 Injection
Phase II: 10 mg	PF-3512676	Phase II: 10 mg flat dose (random assignment in Phase II)
Phase I: 0.28 mg/kg	PF-3512676	Escalating dose groups: 0.28 mg/kg PF-3512676 Injection
Phase I: 0.08 mg/kg	PF-3512676	Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
Phase I: 0.24 mg/kg	PF-3512676	Escalating dose groups: 0.24 mg/kg PF-3512676 Injection
Phase I: 0.36 mg/kg	PF-3512676	Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
Phase II: 25 mg	PF-3512676	Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Primary Outcome Measures

Name	Time	Method
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs	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.	24 weeks

Secondary Outcome Measures

Name	Time	Method
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.	indeterminate