Evaluation of Hypoxia in Primary Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYana Najjar
About this trial
When controlling for tumor present in the Sentinel lymph node (SLN), intranodal hypoxia, as measured by Carbonic Anhydrase IX (CAIX IHC), is associated with worse PFS. This suggests that melanoma tumors may be utilizing deregulated metabolism as a means of propagating themselves to the next station of metastasis. This study aims to prospectively validate previous findings. Patients who are to undergo WLE and SLNB per standard of care (SOC) will be evaluable. It is hypothesized that SLN(s) with increased hypoxia, as measured by pimonidazole staining, will be associated with worse Progression-free Survival (PFS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be willing and able to provide written informed consent for the study.
Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.
Cutaneous or mucosal melanoma is permitted.
Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.
Disqualifiers
Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone > 20 mg daily).
Severe septicemia or severe infection in the 4 weeks prior to study entry.
History of previous neuropathy from chemotherapy or other causes not related to cancer.
Pregnant subjects or breastfeeding subjects. (Note: A pregnancy test will be administered within 7 days prior to the administration of pimonidazole to female subjects of childbearing potential enrolled in the study.)
Trial population
Patients with a histological diagnosis of melanoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pimonidazole
DrugDrug: 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Pimonidazole1 intervention
Trial outcomes
Primary outcomes
1
Tumor Hypoxia
Hypoxia (decreased oxygen levels) in the primary tumor in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Time frame
Day of surgery2
Progression Free Survival
Median number of months from time of surgery to regression, progression or death, whichever occurs first. Progression is defined as observable disease upon visual evaluation of surgical (anatomical) site.
Time frame
Up to 5 years (from date of surgery)3
Sentinel Lymph Node Hypoxia
Hypoxia (decreased oxygen levels) in the sentinel lymph node (SLN) in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Time frame
Day of surgerySecondary outcomes
1
Intra-nodal - intra-tumoral hypoxia correlation
Correlation of hypoxia (decreased oxygen levels) in the sentinel lymph node (SLN) with that of the primary tumor in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Time frame
Day of surgerySponsors and contacts
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Source ClinicalTrials.gov