Characterization of the Melanoma-Specific Immune Response (Melanoma)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease
Melanoma

Detailed 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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	20 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Characterization of the Melanoma-Specific Immune Response
Study Start Date :	August 2007
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	June 2018

Groups and Cohorts

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Group/Cohort
1; Subjects ages 18-85 years old with biopsy proven melanoma. 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; Age-matched controls (no evidence of melanoma)

Outcome Measures

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Primary Outcome Measures :

1. melanoma - peripheral blood [ Time Frame: 2 Years ]
   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.

Secondary Outcome Measures :

1. melanoma - biopsy [ Time Frame: 2 Years ]
   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

Biospecimen Retention:   Samples With DNA

Peripheral blood will be collected prior to initiation of chemotherapy. There will be no more than two blood draws per subject. Most subjects will receive a single blood draw; however, some may be asked to return for an 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects aged 18 years to 85 years who have a biopsy diagnosis of melanoma, and age-matched controls (subjects who do not have a diagnosis of melanoma).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Patients taking immunosuppressive medications

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Emanual Maverakis, M.D.	916-734-1267	emaverakis@ucdavis.edu
Contact: Victoria Wells	916-734-1267	victoria.wells@ucdmc.ucdavis.edu

Locations

United States, California
University of California, Davis Department of Dermatology	Recruiting
Sacramento, California, United States, 95816
Contact: Emanual Maverakis, M.D. 916-734-6556 emaverakis@ucdavis.edu
Contact: Victoria Wells 916-734-1267 victoria.wells@ucdmc.ucdavis.edu
Principal Investigator: Emanual Maverakis, M.D.

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:	Emanual Maverakis, M.D.	University of California, Davis

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of California-Davis Department of Dermatology Clinical Research 

Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00368615 History of Changes
Other Study ID Numbers:	362163
First Posted:	August 25, 2006
Last Update Posted:	March 2, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by University of California, Davis:

melanoma; malignant melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas