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Purpose

This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Must be planned for post-operative immunotherapy - No evidence of distant metastasis as determined by clinical examination and any form of imaging - No evidence of clinically involved lymph nodes prior to SLNB - Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension [ECE] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor) - Has provided written informed consent for participation in this trial - Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less - Life expectancy greater than 6 months - Patients capable of childbearing are using adequate contraception - Available for follow-up

Exclusion Criteria

  • Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN - Distant metastasis - Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues - Women who are pregnant - Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (immunotherapy, radiation therapy) 		Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.
  • Other: Immunotherapy
    All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
    Other names:
    • Immunological
    • Immunological Therapy
    • Immunologically Directed Therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Radiation: Radiation Therapy
    Undergo nodal radiation therapy
    Other names:
    • Cancer Radiotherapy
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
Active Comparator
Group II (immunotherapy) 		Patients planned to undergo immunotherapy.
  • Other: Immunotherapy
    All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
    Other names:
    • Immunological
    • Immunological Therapy
    • Immunologically Directed Therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment

Recruiting Locations

Baptist - MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
Cynthia Anderson, MD
904-202-7300
cynthia.anderson@bmcjax.com

Cooper Hospital UNIV MED CTR.
Camden, New Jersey 08103
Contact:
Gregory Kubicek, MD
855-632-2667
Kubicek-Gregory@CooperHealth.edu

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Devarati Mitra
713-563-1339
dmitra@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Devarati Mitra
713-563-1339
dmitra@mdanderson.org

Detailed Description

PRIMARY OBJECTIVE: I. To determine if regional nodal radiation therapy prolongs the time to regional recurrence. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive adjuvant immunotherapy and nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). GROUP II: Patients receive adjuvant immunotherapy alone. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.