Light Therapy + TIL for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a special light therapy app, used alongside Therapeutic Tumor Infiltrating Lymphocytes (TIL), can help treat advanced melanoma, a skin cancer that has spread. The light therapy aims to reset the body's natural sleep-wake cycle, potentially enhancing the effectiveness of the immune therapy. Individuals with melanoma that did not improve after certain immune treatments and who can read English may be suitable candidates. The combination of therapies aims to be safe and may enhance the body’s ability to fight cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires that you stop using melatonin or sleep aids like zolpidem, trazodone, or benzodiazepines at least 14 days before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What prior data suggests that Circadian-Optimized Light Therapy (COLT) and Therapeutic Tumor Infiltrating Lymphocytes (TIL) are safe for treating advanced melanoma?
Research on Circadian-Optimized Light Therapy (COLT) shows that adding this therapy to standard care for advanced melanoma is safe and manageable. Studies indicate that when light therapy aligns with the body's natural clock, patients often experience fewer severe side effects and improved survival rates compared to traditional treatment timing.
Tumor-Infiltrating Lymphocytes (TIL) therapy, included in the trial, has a strong safety record. This method involves collecting and growing special white blood cells from a patient's tumor to help fight cancer. The FDA has already approved TIL therapy for some cancers, demonstrating its safety in many patients. Overall, previous studies show that patients have well-tolerated these treatments, indicating a positive safety profile.12345Why are researchers excited about this trial's treatments?
Unlike most treatments for skin cancer that focus solely on targeting the cancer cells, this new approach combines therapeutic tumor infiltrating lymphocytes (TIL) with light therapy to enhance treatment effectiveness. TIL therapy involves infusing patients with immune cells that are specifically trained to attack cancer, but the addition of light therapy is aimed at optimizing the body's natural circadian rhythms, potentially boosting the immune response. Researchers are excited because this combination could not only improve the effectiveness of TIL therapy but also help manage side effects and improve patients' overall well-being during treatment.
What evidence suggests that this trial's treatments could be effective for advanced melanoma?
Studies have shown that tumor-infiltrating lymphocyte (TIL) therapy works well for advanced melanoma, a type of skin cancer. In trials, TIL therapy shrank tumors in nearly one-third of patients, and more than half of these patients showed no signs of cancer afterward. Research suggests that TIL therapy can help patients live longer without the cancer worsening, compared to other treatments. In this trial, participants will receive TIL therapy as part of their treatment. Meanwhile, researchers are studying circadian-optimized light therapy (COLT) to help regulate the body's internal clock, which can strengthen the immune system and reduce inflammation. Although direct evidence that COLT helps with cancer is limited, similar light therapies have reduced fatigue and improved overall health. Participants in this trial will also receive COLT, and combining TIL with COLT might enhance melanoma treatment effectiveness.12345
Who Is on the Research Team?
Kelly Mahuron
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced melanoma (skin cancer that has spread) who are receiving tumor-infiltrating lymphocyte (TIL) therapy. Participants must be able to use a digital device at home and follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Participants receive access to the Circadian OS application and begin light therapy sessions daily for 14 days prior to TIL infusion
Treatment
Participants receive standard of care TIL infusion on day 0 and continue daily light therapy sessions for up to 28 days
Optional Extension
Participants may optionally continue COLT for up to 90 days post TIL infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Circadian-Optimized Light Therapy (COLT)
- Therapeutic Tumor Infiltrating Lymphocytes (TIL)
Trial Overview
The study tests whether adding circadian-optimized light therapy (using morning light via an iPad app at home) to standard TIL immunotherapy can help patients with advanced melanoma. It also involves biospecimen collection, questionnaires, and device evaluation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Starting on day -14, patients receive access to the Circadian OS application and within the first hour of waking up undergo light therapy sessions over 1 hour daily between 8:00 and 10:00 am for up to 28 days after TIL in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care TIL infusion on day 0. Patients may optionally continue COLT for up to 90 days post TIL infusion. Patients also wear wrist actigraphy continuously to monitor sleep-wake cycles, light exposure, and circadian rhythms during TIL therapy. Additionally, patients undergo blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Circadian-Optimized Light Therapy for the Treatment of ...
This phase I trial tests the effect of Circadian-Optimized Light Therapy (COLT) in conjunction with standard of care tumor-infiltrating ...
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ctv.veeva.com
ctv.veeva.com/study/circadian-optimized-light-therapy-for-the-treatment-of-patients-with-advanced-melanoma-receiving-tumCircadian-Optimized Light Therapy for the Treatment of ...
This phase I trial tests the effect of Circadian-Optimized Light Therapy (COLT) in conjunction with standard of care tumor-infiltrating ...
Circadian rhythms and cancer: implications for timing in therapy
Chronomodulated chemotherapy has shown improved treatment outcomes, including higher response rates and prolonged survival in patients with ...
Optimizing circadian rhythms and immunotherapy ...
There is evidence for the beneficial effects of bright light therapy (BLT) in cancer patients for improving symptoms like fatigue. We do not yet know how BLT ...
Circadian-optimized chemotherapy improves cancer ...
Circadian-optimized patients showed tumor response rates of 51 percent compared to 29 percent with conventional scheduling — alongside 35 ...
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