CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

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.

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Key information

Conditions

Lymphoma, T-Cell, Cutaneous Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-3512676

Drug

Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Other names: ProMune, CPG 7909

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: Aug 12, 2002
Registry last updated: Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed