Recruiting

Observational Study

Sponsor:

Yana Najjar

Code:

NCT04658303

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pimonidazole

Study Details

Brief 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.

Conditions

Melanoma

Study ID

NCT04658303

Start date

Feb 24, 2021

Status verified date

Jun, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Pimonidazole

Single dose of 0.5 gm/m\^2 of pimonidazole (approximately 13 mg/kg)

Interventions

Pimonidazole

Pimonidazole is not used with therapeutic intent, and has a non-hazardous designation. It has been widely used for in-vivo evaluation of intratumor hypoxia, and patients will take PO pimonidazole before the scheduled biopsy. Patients receive an oral dose of pimonidazole, a safe chemical tracer up to 24 hours prior to biopsy. Pimonidazole allows for true hypoxia staining; pimonidazole binds hypoxic proteins covalently, creating an antigen that facilitates the imaging, flow cytometry, and scRNA-seq experiments proposed. Pimonidazole has been previously used in patients and is safe and well tolerated, without anticipated adverse events.

Primary outcome measure

  • Immunometabolic profiling [ Time Frame: At baseline ]
  • Tumor cell metabolism [ Time Frame: At baseline ]
  • Imaging of individual ITM stations [ Time Frame: At baseline ]
  • hypoxia exposure analyses [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Danielle Bednarz, RN, BSN

412-623-1191bednarzdl@upmc.edu

Amy Rose, RN, BSN

412-647-8587kennaj@upmc.edu

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Amy Rose, RN, BSN

412-647-8587kennaj@upmc.edu

Principal Investigator:

Yana Najjar, MD

More Information

Sponsor

Yana Najjar

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yana Najjar on 2026-06-11.