Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

ConditionMelanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYana Najjar

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pimonidazole

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yana Najjar

Lead sponsor

University of Pittsburgh

Sponsor institution

Hypoxyprobe

Collaborator