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NOT YET RECRUITING
NCT07628894
PHASE1

Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-12-23

Completion Date

2027-07-05

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Internet-Based Intervention

Receive access to Circadian OS application

OTHER

Medical Device Usage and Evaluation

Wear wrist actigraphy

PROCEDURE

Phototherapy

Undergo light therapy sessions

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Therapeutic Tumor Infiltrating Lymphocytes

Given infusion

Locations (1)

City of Hope Medical Center

Duarte, California, United States