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

2026年6月1日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

8

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Duarte、California、美国、91010
        • City of Hope Medical Center
        • 首席研究员：
          • Kelly Mahuron
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：问卷管理
辅助研究
程序：生物样本采集
进行血液样本采集
其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
其他：Internet-Based Intervention
Receive access to Circadian OS application
其他：Medical Device Usage and Evaluation
Wear wrist actigraphy
程序：Phototherapy
Undergo light therapy sessions
其他名称：
  • 强光疗法
  • 光疗法
  • 光疗
生物：Therapeutic Tumor Infiltrating Lymphocytes
Given infusion
其他名称：
  • 肿瘤浸润淋巴细胞

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adherence
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Incidence, severity, and attribution of COLT-related treatment-emergent adverse events
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

City of Hope Medical Center

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Kelly Mahuron、City of Hope Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月23日

初级完成 (估计的)

2027年7月5日

研究完成 (估计的)

2027年7月5日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 25102 (其他标识符：City of Hope Medical Center)
  • P30CA033572 (美国 NIH 拨款/合同)
  • NCI-2026-03733 (注册表标识符：CTRP (Clinical Trial Reporting Program))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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