Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy
2026년 6월 1일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
8
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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수석 연구원:
- Kelly Mahuron
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연락하다:
- Kelly Mahuron
- 이메일: kmahuron@coh.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
보조 연구
혈액 샘플 채취
다른 이름들:
Receive access to Circadian OS application
Wear wrist actigraphy
Undergo light therapy sessions
다른 이름들:
Given infusion
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence
기간: From the start of intervention through the end of the intervention period, assessed up to day 90
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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.
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From the start of intervention through the end of the intervention period, assessed up to day 90
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence, severity, and attribution of COLT-related treatment-emergent adverse events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kelly Mahuron, City of Hope Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 12월 23일
기본 완료 (추정된)
2027년 7월 5일
연구 완료 (추정된)
2027년 7월 5일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25102 (기타 식별자: City of Hope Medical Center)
- P30CA033572 (미국 NIH 보조금/계약)
- NCI-2026-03733 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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