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Therapeutic Areas: Dermatology/Plastic Surgery | Oncology
Disease Category: Melanoma

Trial Information

Participants with Stage IIB-IV Melanoma wanted for a research study.

UVA Health System, Human Immune Therapy Center seeks participants with Stage IIB-IV melanoma for a research study.

The purpose of this study is to identify what goes on with cells at the site where an experimental vaccine is given, in order to improve the usefulness of cancer vaccines. Participants will undergo CT and MRI scans, have physical examinations, answer questions regarding medical history, receive an experimental vaccine, undergo a biopsy of the injection site, and have urine and blood tests as part of this study. There will be 11 study visits over 32 weeks. All participants will receive 6 vaccines over 7 weeks in a primary vaccine site. Participants will be randomly assigned to 1 of 2 study treatment groups which determine the make-up of the vaccine that will be given in a second vaccine site called the replicate vaccine site. Within each study treatment group, participants will also be randomly assigned to 1 of 5 sub-groups to determine the number of replicate vaccine injections they will receive (0, 1, 3, or 6) and the day a piece of skin at the replicate vaccine site will be removed (biopsy) to study the cells in the laboratory (Day 1, 8, 22, 50, or 85). Participants will be asked to complete a symptom diary to monitor the effects to the treatments. Participant or participant's insurance will be responsible for the cost of some required procedures.

There is no compensation available for participants in this study.

Contact Information:
For more information please contact:
Emily Stell, CRC
434-982-6584 or ems2b@virginia.edu
IRB-HSR #13498

Principal Investigator: Craig L. Slingluff, Jr., MD




www.healthsystem.virginia.edu/clinical_trials

Emily M Stell BA
University of Virginia
School of Medicine
Human Immune Therapy Center, Cancer Center
Charlottesville VA 22908
Phone: 434-982-6584
Fax: --
EMail: ems2b@virginia.edu

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