Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Contact Information
Primary
Amy Rose, RN, BSN
kennaj@upmc.edu
412-647-8587
Time Frame
Start Date: 2021-02-24
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 20
Treatments
Pimonidazole
Single dose of 0.5 gm/m\^2 of pimonidazole (approximately 13 mg/kg)
Related Therapeutic Areas
Sponsors
Leads: Yana Najjar
Collaborators: Hypoxyprobe

This content was sourced from clinicaltrials.gov

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