Understanding metabolic and immune changes in melanoma lesions

Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

This study looks at how melanoma lesions change in metabolism and immune response as they spread from the original tumor to see if these changes can help improve treatment options.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: methotrexate, prednisone, immunotherapy
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT04658303 on ClinicalTrials.gov

What this trial studies

This observational study focuses on melanoma in-transit metastases (ITMs) to explore how these lesions evolve metabolically and immunologically as they move away from the primary tumor site. By profiling patient biopsies using advanced techniques such as flow cytometry, metabolic assays, and high-dimensional imaging, the study aims to uncover the unique characteristics of ITMs. It hypothesizes that as these metastases progress, they will exhibit increasingly hypermetabolic tumor cells and a more challenging microenvironment. The findings could provide insights into the management of melanoma and inform future therapeutic strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a histological diagnosis of melanoma and at least two in-transit lesions at varying distances from the primary site.

Not a fit: Patients with in-transit disease that cannot be biopsied or those with chronic immunosuppression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with melanoma in-transit metastases.

How similar studies have performed: While the approach of profiling ITMs is innovative, similar studies have shown promise in understanding tumor microenvironments and immune interactions in other cancer types.

Eligibility criteria

Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial.
2. Be ≥ 18 years of age on day of signing informed consent.
3. A histological diagnosis of melanoma and at least two in-transit lesions at distinct distances from the primary site. Patients may be enrolled on the basis of a diagnosis of in-transit disease by a treating melanoma oncologist.
4. Cutaneous, mucosal or uveal melanoma are permitted.
5. Patients may be on treatment or treatment naïve.
6. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.

Exclusion Criteria:

1. Subjects with in-transit disease that is not amenable to biopsy per the treating physician are excluded.
2. Subjects with known chronic immunosuppression (such as biologic agents like remicade, mycophenolate, methotrexate, prednisone \>20 mg daily).
3. Subjects who are known to be HIV+, Hep B or Hep C positive.

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Yana Najjar, MD — UPMC Hillman Cancer Center
• Study coordinator: Amy Rose, RN, BSN

Conditions Melanoma; immune dysfunction; metabolic dysfunction; Melanoma in-transit metastases; tumor microenvironment