Journal article
Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma
Journal of the American Academy of Dermatology, Vol.63(6), pp.975-983
2010
DOI: 10.1016/j.jaad.2009.12.052
PMID: 20888065
Abstract
Mycosis fungoides and Sézary syndrome are a class of lymphomas of skin-trafficking T cells, and they are the most common forms of cutaneous T-cell lymphoma (CTCL). Mycosis fungoides and Sézary syndrome are chronic, frequently incurable diseases with limited therapeutic options. PF-3512676 (formerly CPG 7909) is a Toll-like receptor 9 agonist that is being investigated for treatment of patients with advanced cancer.
This study was conducted to determine the safety and tolerability of single-agent PF-3512676 in patients with CTCL.
In this phase I dose-escalation study, patients (N = 28) with treatment-refractory, stage IB to IVA CTCL were enrolled in 6 sequential cohorts and treated with PF-3512676 (0.08, 0.16, 0.24, 0.28, 0.32, or 0.36 mg/kg) administered as 24 weekly subcutaneous injections. Primary end points were safety and tolerability.
Common adverse events (fatigue, rigors, injection-site reactions, myalgia, lymphopenia, leukopenia, neutropenia, and pyrexia) were mostly grade 1 or 2, and no patient developed specific symptoms associated with autoimmune disease. Clinical response rate to PF-3512676, as determined by both Composite Assessment of Index Lesion Severity and Physician Global Assessment, was 32% (3 complete clinical responses, 6 partial responses); the majority of responses (7/9; 78%) were ongoing at the end of study.
This trial was not designed to rigorously assess efficacy.
Single-agent PF-3512676 was well tolerated and demonstrated antitumor activity in patients with refractory CTCL.
Details
- Title: Subtitle
- Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma
- Creators
- Youn H Kim - Department of Dermatology, Stanford Cancer Center, Stanford, CaliforniaMichael Girardi - Department of Dermatology, Yale University, New Haven, ConnecticutMadeleine Duvic - Department of Dermatology, University of Texas, MD Anderson Cancer Center, Houston, TexasTimothy Kuzel - Department of Medicine, Division of Hematology/Oncology, Northwestern University, Chicago, IllinoisBrian K Link - Department of Internal Medicine, University of Iowa, Iowa City, IowaLauren Pinter-Brown - Department of Medicine, Division of Hematology/Oncology, University of California at Los Angeles, Los Angeles, CaliforniaAlain H Rook - Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania
- Resource Type
- Journal article
- Publication Details
- Journal of the American Academy of Dermatology, Vol.63(6), pp.975-983
- DOI
- 10.1016/j.jaad.2009.12.052
- PMID
- 20888065
- NLM abbreviation
- J Am Acad Dermatol
- ISSN
- 0190-9622
- eISSN
- 1097-6787
- Publisher
- Mosby, Inc
- Grant note
- Pfizer Merck and Hy BioPharma Pfizer Inc Coley
- Language
- English
- Date published
- 2010
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984094539902771
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