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Therapeutic Areas: Dermatology/Plastic Surgery | Oncology
Disease Category: Melanoma
Trial Information
DERMA Clinical Research Study in Melanoma MAGE-A3 Immunotherapy
The DERMA Clinical Research study will test a potential new treatment for melanoma to see how well it works and if it is safe. The purpose of the study is to see if this new treatment can delay or prevent melanoma coming back.
Patient Inclusion Criteria:
- Written informed consent for MAGE-A3 expression, gene profiling and the complete study
- Histologically proven stage IIIB or IIIC cutaneous melanoma with macroscopic lymph node involvement
- Free of disease after surgery
- 18 years of age or older
- MAGE-A3 positive lymph node
- Recovered from surgery
- ECOG performance status of 0 or 1
- Adequate organ function
- Contraception from 30 days prior to randomization for females of childbearing potential
- Patient can and will comply with study requirements
Patient Exclusion Criteria:
- Mucous membrane or ocular melanoma
- In-transit metastases
- Adjuvant anti-cancer treatment
- Concomitant chronic treatment with systemic corticosteroids, or any other immunosuppressive agents
- Treatment with investigational or non-registered medicinal product
- History of autoimmune disease except for vitiligo
- Family history of congenital or hereditary immunodeficiency
- HIV-positive
- History of allergic disease or allergy to any component of investigational product
- Psychiatric or addictive disorders
- Concurrent medical problems that would limit full compliance with the study
- Previous or concomitant malignancies
- Uncontrolled bleeding disorder
- Pregnant or lactating female patient
Monica Dunn, RN, BSN, Clinical Coordinator
Kenneth Beer MD, PA
1500 N. Dixie Highway, Suite 305
West Palm Beach, FL 33401
Phone: (561) 655-9055
Fax: (561) 655-9233
EMail: madmay2@aol.com
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Research Center Information: Kenneth Beer MD, PA
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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