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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
8
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Duarte、California、アメリカ、91010
- City of Hope Medical Center
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主任研究者：
- Kelly Mahuron
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コンタクト：
- Kelly Mahuron
- メール：kmahuron@coh.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
補助研究
採血を受ける
他の名前：
Receive access to Circadian OS application
Wear wrist actigraphy
Undergo light therapy sessions
他の名前：
Given infusion
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence, severity, and attribution of COLT-related treatment-emergent adverse events
時間枠：From the first day of COLT administration through 30 days after completion of intervention
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Will be graded by Common Terminology Criteria for Adverse Events version 5.0.
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From the first day of COLT administration through 30 days after completion of intervention
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|
Patient-reported acceptability and usability of COLT
時間枠：Up to day 90
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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.
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Up to day 90
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Patient scores for quality of life and symptom burden
時間枠：Up to day 90
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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.
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Up to day 90
|
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Patient scores for fatigue
時間枠：Up to day 28
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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.
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Up to day 28
|
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Patient scores for depression
時間枠：Up to day 90
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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.
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Up to day 90
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Kelly Mahuron、City of Hope Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年12月23日
一次修了 (推定)
2027年7月5日
研究の完了 (推定)
2027年7月5日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25102 (その他の識別子：City of Hope Medical Center)
- P30CA033572 (米国 NIH グラント/契約)
- NCI-2026-03733 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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