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Characterization of the Melanoma-Specific Immune Response

Phase 4
18 Years
85 Years
Open (Enrolling)

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Trial Information

Characterization of the Melanoma-Specific Immune Response

The aim of the study is to in-vitro characterize and expand T cells specific for
melanoma-derived antigens. Peripheral blood with be collected from 20 volunteers with biopsy
proven melanoma and 10 age matched controls. Blood will be collected prior to the
initiation of chemotherapy. There will be no more than two blood draws per patient. Most
patients will receive a single blood draw; however, some participants may be asked to return
for a single additional blood draw if investigators were unable to isolate melanoma-specific
immune cells after the first blood draw. Two separate blood draws will be the maximum.
The interval between these blood draws will be a minimum of 3 months apart. Blood samples
will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the
patient's haplotype has been established melanoma-specific T cell clones will be generated
from the peripheral blood samples and expanded in-vitro. These clones will then be assayed
for specificity against commercially available melanoma cell lines. The T cell clones will
also be assayed for reactivity to melanocyte differentiation antigens such as MART-1 and
gp100. If the volunteer requires a palliative resection of a melanoma tumor then the
patient's own tumor cells may also be used to test the specificity of the isolated T cell
clones. All experiments will be conducted in-vitro.

Inclusion Criteria:

- Biopsy diagnosis of malignant melanoma

- Have had a biopsy diagnosis of malignant melanoma in the past

Exclusion Criteria:

- Patients taking immunosuppressive medications

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:


Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Emanual Maverakis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

November 2011

Related Keywords:

  • Melanoma
  • melanoma
  • malignant melanoma
  • Melanoma



University of California, Davis Department of Dermatology Sacramento, California  95816