Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
Recruiting · NCT04658303 · Observational (researchers observe without assigning treatment) · Lead sponsor: Yana Najjar
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Melanoma in-transit metastases (ITMs) continue to represent a therapeutic dilemma, in that no standard method of treatment has been uniformly adopted. The complexity and heterogeneity of patient and disease characteristics, including the location and number of ITMs presents a barrier to a one size fits all treatment approach. Treatment of patients with limited regional disease remains challenging. Patients are typically treated with a combination of surgery, regional therapy, systemic therapy. Data on the management of ITMs is limited, even with the availability of immunotherapy (IMT). This study will use the unique etiology of ITMs to facilitate the understanding of how individual lesions metabolically and immunologically evolve as they move away from the primary tumor site. It is hypothesize that as ITMs move away from the primary melanoma site each will harbor progressively hypermetabolic tumor cells and a harsher microenvironment.
Who can take part
Inclusion criteria
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- 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.
- Cutaneous, mucosal or uveal melanoma are permitted.
- Patients may be on treatment or treatment naïve.
- 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
- Subjects with in-transit disease that is not amenable to biopsy per the treating physician are excluded.
- Subjects with known chronic immunosuppression (such as biologic agents like remicade, mycophenolate, methotrexate, prednisone \>20 mg daily).
- Subjects who are known to be HIV+, Hep B or Hep C positive.
Where it is running
1 location listed across 1 US state.
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States