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

1 juin 2026 mis à jour par: City of Hope Medical Center

A Single-Center, Prospective Pilot Trial of Circadian-Optimized Light Therapy (COLT) in Patients Undergoing Tumor-Infiltrating Lymphocyte (TIL) Therapy for Metastatic Melanoma

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of COLT with TIL therapy.

SECONDARY OBJECTIVES:

I. Evaluate the safety of COLT with TIL therapy. II. Evaluate the acceptability of COLT intervention to patients. III. Evaluate the effect of COLT on patient-reported quality of life metrics.

EXPLORATORY OBJECTIVES:

I. Evaluate changes that occur in patient circadian clocks with COLT during TIL therapy using actigraphy and circadian clock gene analysis.

II. Evaluate the alterations and time course that occur in tumor immune cell subsets and phenotype with COLT during TIL therapy.

III. Evaluate the toxicities related to TIL therapy (i.e., cytopenia, interleukin 2 [IL-2] toxicity) that occur with COLT during TIL therapy.

OUTLINE:

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.

After completion of study intervention, patients are followed up at 30 days.

Type d'étude

Interventionnel

Inscription (Estimé)

8

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Duarte, California, États-Unis, 91010
        • City of Hope Medical Center
        • Chercheur principal:
          • Kelly Mahuron
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorized representative
  • Age: ≥ 18 years
  • Ability to read and understand English for questionnaires
  • Progression on or after immune checkpoint inhibitor therapy
  • Deemed eligible and consented for standard-of-care TIL therapy (lifileucel/Amtagvi)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (typically required for TIL therapy; confirm with clinical standards of practice [SOP])

Exclusion Criteria:

  • Explicit Munich Chronotype Questionnaire (MCTQ) cutoffs (< 2:00, > 5:00)
  • Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment
  • Night shift work within the past 30 days or expected during the intervention
  • Travel across ≥ 2 time zones within the past 14 days
  • Diagnosed or suspected untreated moderate to severe obstructive sleep apnea
  • History of mania, hypomania, bipolar disorder, migraine (with or without photophobia), or active seizure disorder
  • Active psychosis, suicidal ideation, or recent psychiatric hospitalization (< 3 months)
  • Ocular conditions exacerbated by bright light exposure
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treatment (COLT, TIL)
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.
Autre: Gestion des questionnaires
Etudes annexes
Procédure: Collecte d'échantillons biologiques
Subir une collecte d'échantillons de sang
Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Autre: Internet-Based Intervention
Receive access to Circadian OS application
Autre: Medical Device Usage and Evaluation
Wear wrist actigraphy
Procédure: Phototherapy
Undergo light therapy sessions
Autres noms:
  • Thérapie par la lumière vive
  • luminothérapie
  • Actinothérapie
Biologique: Therapeutic Tumor Infiltrating Lymphocytes
Given infusion
Autres noms:
  • Lymphocytes infiltrant la tumeur

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adherence
Délai: From the start of intervention through the end of the intervention period, assessed up to day 90
Will be measured as the proportion of prescribed daily Circadian-Optimized Light Therapy (COLT) sessions attempted by each participant. Session initiation, duration, and completion will be automatically recorded by the Circadian OS application and verified at scheduled study visits. Participants who attempt at least 50% of sessions will be considered adherent. Adherence data will be summarized descriptively, including the median and range of completion rates across participants. Will be reported with a two-sided 95% exact (Clopper-Pearson) confidence interval.
From the start of intervention through the end of the intervention period, assessed up to day 90

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence, severity, and attribution of COLT-related treatment-emergent adverse events
Délai: From the first day of COLT administration through 30 days after completion of intervention
Will be graded by Common Terminology Criteria for Adverse Events version 5.0.
From the first day of COLT administration through 30 days after completion of intervention
Patient-reported acceptability and usability of COLT
Délai: Up to day 90
Will be assessed using the Acceptability of Intervention Measure questionnaire. Responses will be summarized as total and subscale scores with means, standard deviations, medians, and ranges. The proportion of participants meeting a predefined threshold for acceptability or usability on the instrument's scale will also be reported with exact 95 percent confidence intervals.
Up to day 90
Patient scores for quality of life and symptom burden
Délai: Up to day 90
Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Up to day 90
Patient scores for fatigue
Délai: Up to day 28
Will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Up to day 28
Patient scores for depression
Délai: Up to day 90
Will be evaluated using PROMIS Depression questionnaire. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Up to day 90

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

City of Hope Medical Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Kelly Mahuron, City of Hope Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

23 décembre 2026

Achèvement primaire (Estimé)

5 juillet 2027

Achèvement de l'étude (Estimé)

5 juillet 2027

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25102 (Autre identifiant: City of Hope Medical Center)
  • P30CA033572 (Subvention/contrat des NIH des États-Unis)
  • NCI-2026-03733 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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