Guiding melanoma surgery in children using pathology and genetics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial studies a risk-based approach to deciding how much surgery is needed for children with localized cutaneous melanoma or related melanocytic tumors. Researchers will classify tumors as not atypical, atypical but low risk, or atypical and high risk based on pathology and genetic markers, and then guide primary surgical management accordingly. The study also tracks how well surgeons follow protocol-driven plans, the safety of different surgical approaches, and outcomes such as progression-free and overall survival. Exploratory aims describe reconstruction techniques and details around sentinel node procedures and nodal dissection. Interventions include biospecimen collection and various imaging modalities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients ≤ 25 years old
* Newly diagnosed localized cutaneous melanoma, atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report
* Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
* Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy/excision of the lesion for which they are enrolling. Note that prior biopsies/surgery for other benign melanocytic lesions is permitted

Exclusion Criteria:

* Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasms are eligible
* Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible
* Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy/excision, including re-biopsy, of the lesion
* Any of the following diagnoses

  * Congenital nevi-associated proliferative nodules
  * Agminated Spitz nevi/tumors
  * Dysplastic nevus
  * Combined nevus
  * CRTC1::TRIM11 and/or MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)
* Pre-existing conditions:

  * Solid organ transplant recipients
  * Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Where it's running

• Kaiser Permanente-Oakland
  Oakland, California, United States Recruiting
• Alfred I duPont Hospital for Children
  Wilmington, Delaware, United States Recruiting
• Nemours Children's Clinic-Jacksonville
  Jacksonville, Florida, United States Recruiting
• Nemours Children's Hospital
  Orlando, Florida, United States Recruiting
• Nemours Children's Clinic - Pensacola
  Pensacola, Florida, United States Recruiting
• ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  Toledo, Ohio, United States Recruiting

Study contacts

• Principal investigator: Brittani K Seynnaeve — Children's Oncology Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.