Clinical trial

Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

Name

HCC 20-263

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.

Trial arms

Trial start

2021-02-24

Estimated PCD

2027-03-01

Trial end

2027-03-01

Status

Recruiting

Treatment

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.

Arms:

Pimonidazole

Size

Primary endpoint

Immunometabolic profiling

At baseline

Tumor cell metabolism

At baseline

Imaging of individual ITM stations

At baseline

hypoxia exposure analyses

At baseline

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biopsy of 2-5 lesions from each individual patient. 1-3 core or punch biopsies are permitted per lesion\n\nBlood will be collected the time of biopsy for correlative analyses (128.5 cc)'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-07

1 organization

1 product

1 indication

Organization

Yana Najjar

Product

Pimonidazole

Indication

Melanoma