Melanoma Clinical Trial

Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma

Summary

The goal of this proposal is to determine how cannabinoid use affects the tumor immune microenvironment (TME) of melanoma by correlating TILs with reported cannabinoid use and circulating plasma cannabinoids. The central hypothesis is that cannabinoid use decreases TILs in melanoma in a dose-dependent fashion. This is important because cannabinoid-driven TME changes in melanoma may alter patient outcomes mediated by TILs and response to standard of care ICI treatments.

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Full Description

Specific Aim 1.Assess how systemic cannabinoids remodel tumor infiltrating lymphocytes (TILs) within the melanoma tumor microenvironment. We hypothesize that decreased grade of TILs and exhaustive differentiation of T cells in melanoma are associated with lower cannabinoid receptor (CB1/CB2) expression and higher levels of systemic exogenous cannabinoids. Aim 1a.) Correlate plasma levels of cannabinoids with TIL grade. Aim 1b.) Correlate plasma levels of cannabinoids with TIL T cell immunohistochemical markers of exhaustion. Aim 1c.) Correlate plasma levels of cannabinoids to TIL CB1/CB2 expression.

Specific Aim 2. Determine the relationship between peripheral T cell activation and circulating cannabinoid levels in patients with melanoma. We hypothesize that the phenotypic activation of peripheral T cells is inversely associated with increased plasma levels of systemic exogenous cannabinoids. Aim 2a.) Immunophenotype peripheral T cells from patients with melanoma. Aim 2b.) Correlate plasma levels of cannabinoids with peripheral T cell phenotypic activation.

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Eligibility Criteria

Inclusion Criteria:

Biopsy proven melanoma, any stage

Biopsy obtained within 4 weeks of anticipated enrollment
Patients >21 years old
Report no cannabis use in the last year or chronic cannabis use (at least weekly use for 3 months or more)

Exclusion Criteria:

Patients unwilling or unable to provide informed consent

Study is for people with:

Melanoma

Estimated Enrollment:

90

Study ID:

NCT05520294

Recruitment Status:

Active, not recruiting

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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University of Colorado Denver
Aurora Colorado, 80045, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

90

Study ID:

NCT05520294

Recruitment Status:

Active, not recruiting

Sponsor:


University of Colorado, Denver

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