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Characterization of the Melanoma-Specific Immune Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368615
First received: August 24, 2006
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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 Phase
Melanoma
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of the Melanoma-Specific Immune Response

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • melanoma [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • melanoma [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 20
Study Start Date: August 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects with biopsy proven melanoma
2
Age-matched controls (no evidence of 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368615

Contacts
Contact: Emanual Maverakis, MD 916-734-1267 emaverakis@ucdavis.edu
Contact: Jamie Chapman 916-734-1267 jamie.chapman@ucdmc.ucdavis.edu

Locations
United States, California
University of California, Davis Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Emanual Maverakis, MD    916-734-6556    emaverakis@ucdavis.edu   
Contact: Jamie Chapman    916-734-1267    jamie.chapman@ucdmc.ucdavis.edu   
Principal Investigator: Emanual Maverakis, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Emanual Maverakis, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Emanual Mavarakis, MD, University of California Davis
ClinicalTrials.gov Identifier: NCT00368615     History of Changes
Other Study ID Numbers: 200513097-1
Study First Received: August 24, 2006
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
melanoma
malignant melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 25, 2014