RECRUITING

Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

Quick Facts

Study Start:2021-02-24
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04658303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be willing and able to provide written informed consent for the trial.
  2. 2. Be ≥ 18 years of age on day of signing informed consent.
  3. 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. 4. Cutaneous, mucosal or uveal melanoma are permitted.
  5. 5. Patients may be on treatment or treatment naïve.
  6. 6. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.
  1. 1. Subjects with in-transit disease that is not amenable to biopsy per the treating physician are excluded.
  2. 2. Subjects with known chronic immunosuppression (such as biologic agents like remicade, mycophenolate, methotrexate, prednisone \>20 mg daily).
  3. 3. Subjects who are known to be HIV+, Hep B or Hep C positive.

Contacts and Locations

Study Contact

Amy Rose, RN, BSN
CONTACT
412-647-8587
kennaj@upmc.edu

Principal Investigator

Yana Najjar, MD
PRINCIPAL_INVESTIGATOR
UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Yana Najjar

  • Yana Najjar, MD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-24
Study Completion Date2027-03

Study Record Updates

Study Start Date2021-02-24
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • immune dysfunction
  • metabolic dysfunction
  • Melanoma in-transit metastases (ITMs)
  • tumor microenvironment (TME)

Additional Relevant MeSH Terms

  • Melanoma