Characterization of the Melanoma-Specific Immune Response

Melanoma Clinical Trial

— Melanoma  

Official title:

Characterization of the Melanoma-Specific Immune Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00368615
• Other study ID #: 362163
• Status: Recruiting
• Start date: August 2007
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: University of California, Davis
• Contact: Emanual Maverakis, M.D.
• Phone: 916-734-1267
• Email: emaverakis[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Biopsy diagnosis of malignant melanoma

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

Exclusion Criteria:

• Patients taking immunosuppressive medications

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	University of California, Davis Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	melanoma - peripheral blood	Peripheral blood will be collected from adults ages 18-85 years old. These samples will then be used for PCR analysis and to generate melanoma-specific T cell clones. If the participant requires a palliative resection of a melanoma tumor(s) then tissue from the tumor will be used to characterize the melanoma's interaction with the immune system and to generate melanoma-specific cell lines. T cell clones isolated from participant's peripheral blood will then be assayed for in-vitro responsiveness to these cell lines. All experiments will be conducted in-vitro.	2 Years
Secondary	melanoma - biopsy	Patients will not be required to have a biopsy to participate in the study but those who give their consent will undergo a skin biopsy. The biopsy will be used to characterize the skin-infiltrating inflammatory cells. The gene-expression profile of these cells will be determined. Each patient who provides consent will undergo two biopsies, one of lesional skin and the other of normal lesional skin as control. Patients who develop multiple cutaneous tumors may be reconsented for an additional two biopsies	2 Years

External Links

•   Learn more or sign up for the study here!
•   University of California-Davis Department of Dermatology Clinical Research