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

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Melanoma

Treatments: Other: High-performance liquid chromatography-tandem mass spectrometry assays

Study type: Observational

Funder types: Other

Identifiers

NCT05520294

22-1132

Details and patient eligibility

About

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.

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

Chronic Cannabinoid Users

Description:

Ib or II Melanoma patients who are chronic cannabinoid users

Treatment:

Other: High-performance liquid chromatography-tandem mass spectrometry assays

Non-users

Description:

Ib or II Melanoma patients non cannabinoid users

Treatment:

Other: High-performance liquid chromatography-tandem mass spectrometry assays