Abstract | PURPOSE: To report the protocol for surveillance of the eye and vision in a clinical trial of MART1-transduced dendritic cells for metastatic melanoma. METHODS: In a phase I/II clinical trial of dendritic cell-based genetic immunotherapy for metastatic cutaneous melanoma, ophthalmic evaluation is performed prior to immunization (Baseline Evaluation), 56+/-7 days after first vaccination (mid-study evaluation), when dendritic cell injections are complete 112+/-7 days after first vaccination (end-study evaluation) and 168+/-7 days after first vaccination (post-study evaluation). RESULTS: The protocol for baseline, mid-study and end-study evaluations of the eye and vision includes ophthalmic history, comprehensive ophthalmic examination, psychophysical and electrophysiological visual function assessment, fundus photography and fluorescein angiography. Post-study evaluation consists of the 25-item visual functioning questionnaire augmented to elicit autoimmune manifestation with complete ophthalmic evaluation if vision-related symptoms or abnormalities are noted during or after the vaccination. CONCLUSION:
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Authors | Lynn K Gordon, Antoni Ribas, Steven Nusinowitz, Lisa H Butterfield, John A Glaspy, James S Economou, Bradley R Straatsma |
Journal | Controlled clinical trials
(Control Clin Trials)
Vol. 25
Issue 4
Pg. 400-7
(Aug 2004)
ISSN: 0197-2456 [Print] United States |
PMID | 15296814
(Publication Type: Journal Article)
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Chemical References |
- Antigens, Neoplasm
- Cancer Vaccines
- MART-1 Antigen
- MLANA protein, human
- Neoplasm Proteins
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Topics |
- Antigens, Neoplasm
- Cancer Vaccines
(immunology, therapeutic use)
- Cell Transformation, Neoplastic
(immunology)
- Clinical Trials as Topic
- Contrast Sensitivity
- Dendritic Cells
(drug effects, immunology, transplantation)
- Dose-Response Relationship, Immunologic
- Electroretinography
(methods)
- Eye Diseases
(diagnosis)
- Genetic Therapy
(methods)
- Humans
- Immunotherapy
(methods)
- Injections, Intradermal
- MART-1 Antigen
- Melanoma
(immunology, therapy)
- Neoplasm Proteins
(genetics, immunology)
- Population Surveillance
(methods)
- Skin Neoplasms
(immunology, therapy)
- Transduction, Genetic
(methods)
- Vaccination
(methods)
- Vision Disorders
(diagnosis)
- Visual Acuity
(physiology)
- Visual Fields
(physiology)
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