Surveillance of the Eye and Vision in Clinical Trials of CP-675,206 for Metastatic Melanoma

Straatsma, Bradley R.; Nusinowitz, Steven; Young, Tara A.; Gordon, Lynn K.; Chun, Melissa W.; Rosen, Colleen; Seja, Elisabeth; Economou, James S.; Glaspy, John A.; Bozon, Viviana; Gomez-Navarro, Jesus; Ribas, Antoni

doi:10.1016/j.ajo.2007.02.035

« Previous Next »American Journal of Ophthalmology
Volume 143, Issue 6 , Pages 958-969.e2, June 2007

Surveillance of the Eye and Vision in Clinical Trials of CP-675,206 for Metastatic Melanoma

Bradley R. Straatsma
- Department of Ophthalmology, University of California, Los Angeles, Los Angeles, California
- Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California
- Inquiries to Bradley R. Straatsma, Department of Ophthalmology and Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, 100 Stein Plaza, Los Angeles, CA 90095
Steven Nusinowitz
- Department of Ophthalmology, University of California, Los Angeles, Los Angeles, California
- Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California
Tara A. Young
- Department of Ophthalmology, University of California, Los Angeles, Los Angeles, California
- Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California
Lynn K. Gordon
- Department of Ophthalmology, University of California, Los Angeles, Los Angeles, California
- Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California
Melissa W. Chun
- Department of Ophthalmology, University of California, Los Angeles, Los Angeles, California
- Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California
Colleen Rosen
- Department of Ophthalmology, University of California, Los Angeles, Los Angeles, California
Elisabeth Seja
- Division of Hematology/Oncology, Department of Medicine, University of California, Los Angeles, Los Angeles, California
James S. Economou
- Division of Surgical Oncology, Department of Surgery, University of California, Los Angeles, Los Angeles, California
- Department of Microbiology, Immunology and Mole Genetics, University of California, Los Angeles, Los Angeles, California
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California
John A. Glaspy
- Division of Hematology/Oncology, Department of Medicine, University of California, Los Angeles, Los Angeles, California
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California
Viviana Bozon
- Pfizer Global Research and Development, New London, Connecticut.
Jesus Gomez-Navarro
- Pfizer Global Research and Development, New London, Connecticut.
Antoni Ribas
- Division of Hematology/Oncology, Department of Medicine, University of California, Los Angeles, Los Angeles, California
- Division of Surgical Oncology, Department of Surgery, University of California, Los Angeles, Los Angeles, California
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California

Accepted 16 February 2007. published online 31 March 2007.

Purpose

To determine the ocular safety of CP-675,206 (Pfizer, New York, New York, USA), a fully human anti–cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody in clinical trials of immunotherapy of metastatic melanoma.

Design

Prospective, nonrandomized study of the eye and vision in phase I/II clinical trials of CP-675,206 in metastatic melanoma conducted at the University of California, Los Angeles.

Methods

Patients with regional or distant metastatic melanoma were enrolled in phase I/II clinical trials evaluating the safety and antitumor efficacy of CP-675,206 alone or in combination with melanoma antigen peptide-pulsed dendritic cell vaccines. Ophthalmic evaluation was performed at the onset of CP-675,206 immunotherapy (baseline evaluation), two months or more after the onset of CP-675,206 immunotherapy (end-study evaluation), and at two- to three-month intervals thereafter in patients who continued to receive CP-675,206 immunotherapy (poststudy evaluation). Baseline and end-study evaluations included comprehensive ophthalmic examination, psychophysical and electrophysiologic visual function assessment, fundus photography, fluorescein angiography, and visual function assessment.

Results

Twenty patients with metastatic melanoma arising from the skin, mucosa, eye, or unknown site were evaluated. Systemic toxicity attributed to CP-675,206 included dermatologic manifestations, diarrhea, and autoimmune hepatitis with panhypopituitarism. A subset of patients receiving CP-675,206 demonstrated antitumor efficacy with partial response or complete response of metastatic melanoma. Comparison of ophthalmic baseline with end-study evaluations in all 20 patients and limited-term poststudy evaluations showed no adverse effect of CP-675,206 immunotherapy on the eye or vision.