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Advanced Cutaneous MelanomaDigital healthSleepProcedureBiologicalPhase 1

What this study is

This phase I trial tests the effect of Circadian-Optimized Light Therapy (COLT) in conjunction with standard of care tumor-infiltrating lymphocytes (TIL) therapy in treating patients with melanoma that may have spread from where it first started to nearby tissue, lymph nodes or distant parts of the body (advanced). Circadian rhythm is the body's natural 24 hour clock which helps keep the body operating on a healthy wake-sleep cycle. Exposure to morning light has been shown to have a positive impact. Patients with advanced cancers often experience circadian disruption, including exposure to hospital-related light, treatment side effects, and inflammation. TIL are made by collecting and growing specialized T cells (a type of white blood cell) from a patient's tumor and given back to the patient to help stimulate the immune system in different ways to stop tumor cells from growing. However, disruptions in the circadian rhythm may impact the effectiveness of TIL therapy. COLT is a home-based digital intervention that delivers circadian-effective morning light using the Circadian OS iPad application. Daily light exposure may help prevent circadian disruption and improve immune and inflammatory responses. Adding COLT sessions to standard of care therapy with TIL may be safe and tolerable in patients with advanced melanoma.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Internet-Based Intervention

    Intervention · OTHER

    Receive access to Circadian OS application

  • Medical Device Usage and Evaluation

    Intervention · OTHER

    Wear wrist actigraphy

  • Phototherapy

    Intervention · PROCEDURE

    Undergo light therapy sessions

  • Questionnaire Administration

    Intervention · OTHER

    Ancillary studies

  • Therapeutic Tumor Infiltrating Lymphocytes

    Intervention · BIOLOGICAL

    Given infusion

Study details

Official title
A Single-Center, Prospective Pilot Trial of Circadian-Optimized Light Therapy (COLT) in Patients Undergoing Tumor-Infiltrating Lymphocyte (TIL) Therapy for Metastatic Melanoma
Sponsor
City of Hope Medical Center
Conditions
Advanced Cutaneous Melanoma · Clinical Stage III Cutaneous Melanoma AJCC v8 · Clinical Stage IV Cutaneous Melanoma AJCC v8 · Metastatic Cutaneous Melanoma
Enrolling
8 people
Starts
2026-12-23
Est. completion
2027-07-05
Design
Open-label, single group, Phase 1
Record
View on ClinicalTrials.gov ↗