Light Therapy + TIL for Skin Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

KM

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

Documented informed consent of the participant and/or legally authorized representative
Ability to read and understand English for questionnaires
I am 18 years old or older.
See 3 more

Exclusion Criteria

Explicit Munich Chronotype Questionnaire (MCTQ) cutoffs (< 2:00, > 5:00)
Any other condition contraindicating participation due to safety concerns with clinical study procedures
Participants who may not be able to comply with all study procedures due to feasibility or logistics concerns
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-Treatment

Participants receive access to the Circadian OS application and begin light therapy sessions daily for 14 days prior to TIL infusion

2 weeks
Daily home-based sessions

Treatment

Participants receive standard of care TIL infusion on day 0 and continue daily light therapy sessions for up to 28 days

4 weeks
Daily home-based sessions, TIL infusion on day 0

Optional Extension

Participants may optionally continue COLT for up to 90 days post TIL infusion

Up to 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Follow-up visit at 30 days post-intervention

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

Group I: Treatment (COLT, TIL)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

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