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Characterization of the Melanoma-Specific Immune Response

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Biomarker/Laboratory analysis Active 18 to 85 Other 200513097-1
NCT00368615

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University of California Davis Cancer Center

Emanual Maverakis, M.D.

Principal Investigator

Jennifer Nava		Ph: 916-734-1438
		Email: jennifer.nava@ucdmc.ucdavis.edu

Sepideh Bagheri, M.D.		Ph: 916-734-6547
		Email: sepideh.bagheri@ucdmc.ucdavis.edu

Trial Sites

U.S.A.

California

Sacramento

University of California Davis Cancer Center

Emanual Maverakis, M.D. Ph: 916-734-1438

Email: emanual.maverakis@ucdmc.ucdavis.edu

Jennifer Nava Ph: 916-734-1438

Email: jennifer.nava@ucdmc.ucdavis.edu

Emanual Maverakis, M.D. Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00368615
Information obtained from ClinicalTrials.gov on March 05, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.