A Multi-Institutional Central Pathology and Molecular Risk-Based Stratification Study of Surgical Management for Melanoma, Atypical Spitz/Spitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients
Children's Oncology Group
Summary
This phase II trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz/Spitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and/or recurrence (coming back after a period of improvement), and atypical and high risk for spread and/or recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz/Spitzoid tumors or other atypical melanocytic tumors.
Description
PRIMARY OBJECTIVE: I. To study the feasibility of central risk-based stratification of malignant and atypical cutaneous melanocytic tumors to guide primary surgical management. SECONDARY OBJECTIVES: I. To evaluate the adherence rate to protocol-assigned surgical management in children with newly diagnosed melanoma, atypical Spitz/Spitzoid tumors, and other atypical melanocytic neoplasms. II. To evaluate the surgery-related adverse events profile for patients treated with narrow re-excision without sentinel lymph node biopsy versus wide local excision +/- sentinel lymph node biopsy per stan…
Eligibility
- Age range
- Up to 25 years
- Sex
- All
- Healthy volunteers
- No
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 Karnof…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureChest Radiography
Undergo chest x-ray
- ProcedureComputed Tomography
Undergo CT or FDG PET/CT
- OtherFludeoxyglucose F-18
Given FDG
- ProcedureMagnetic Resonance Imaging
Undergo MRI, PET/MRI or brain MRI
- OtherPatient Observation
Undergo observation
- ProcedurePositron Emission Tomography
Undergo whole body FDG PET/CT or PET/MRI
- ProcedureRe-Excision
Undergo narrow margin re-excision
- ProcedureSentinel Lymph Node Biopsy
Undergo SLNB
- ProcedureUltrasound Imaging
Undergo nodal basin ultrasound
- ProcedureWide Local Excision
Undergo wide local excision
Locations (13)
- Kaiser Permanente-OaklandOakland, California
- Alfred I duPont Hospital for ChildrenWilmington, Delaware
- Nemours Children's Clinic-JacksonvilleJacksonville, Florida
- Nemours Children's HospitalOrlando, Florida
- Nemours Children's Clinic - PensacolaPensacola, Florida
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, Ohio