수술이 불가능한 악성 중심기도 폐쇄 환자 치료에서 완화 방사선요법에 따른 간질성 광역학 치료
수술이 불가능한 악성 중앙 기도 폐쇄 환자를 위한 완화 방사선 치료 후 간질성 광역학 치료에 대한 제I/II상 연구
This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PRIMARY OBJECTIVES:
I. To test the safety of our image-based treatment planning for image-guided interstitial photodynamic therapy (I PDT) with endobronchial ultrasound (EBUS) following standard of care palliative radiotherapy (p-XRT). (Phase I)
-To assess the efficacy of our image-based treatment planning for image-guided I-PDT following standard of care p-XRT. (Phase II)
SECONDARY OBJECTIVES:
- To assess objective tumor response. (Phase I)
- To evaluate changes in quality of life. (Phase I and II)
- To measure changes in functional lung capacity. (Phase I and II)
- To measure the relationship between the measured objective tumor response (at 12 +/- 2 weeks post I-PDT) and changes in therapeutic laser light transmission within the target tumor, as a future dosimetric marker for response. (Phase I and II)
- To assess treatment effects on the immune contexture. (Phase I and II)
- To monitor progression free survival. (Phase I and II)
OUTLINE: This is a phase I study, followed by a phase II.
PHASE I: Patients are assigned to 1 of 2 cohorts.
COHORT 1: Patients receive visudyne intravenously (IV) over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo computed tomography (CT) throughout the trial.
COHORT 2: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.
PHASE II: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.
After completion of study treatment, patients are followed up at 30 days and 8, 12, and 24 weeks.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: ASKRPCI@RoswellPark.org
- 전화번호: 1-877-275-7724
- 이메일: askrpci@roswellpark.org
연구 장소
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New York
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Buffalo, New York, 미국, 14263
- 모병
- Roswell Park Cancer Institute
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연락하다:
- Nathaniel Ivanick
- 전화번호: 716-845-5873
- 이메일: Nathaniel.Ivanick@RoswellPark.org
-
수석 연구원:
- Nathaniel Ivanick
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- Abramson Cancer Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age >= 18 years of age
- Eligibility checklist before registration requires review of case by the interventional pulmonologist/s and radiation oncologist/s to approve anatomic feasibility of an airway intervention and palliative radiotherapy
- Patients with pathologic diagnosis of inoperable solid malignancy involving extrabronchial tumor growth that causes airway obstruction and not amenable to curative radiotherapy. All patients will have tumors requiring bronchoscopic intervention with endobronchial ultrasound (EBUS) at the time of I-PDT
- Participants have at least one measurable lesion which is also the target lesion for Response Evaluation Criteria in Solid Tumors (RECIST) measurement
- Patients amenable to receive standard of care palliative radiotherapy to the target tumor, as determined by the radiation oncologist/s
- Amenable to high resolution chest computed tomography (CT) scan (with or without contrast due to contraindication) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm
- Tumor is accessible and amenable to I-PDT, as determined by the interventional pulmonologist/s
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
- Platelets ≥ 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L)
- International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5 x ULN. PTT or aPTT per institutional standards for participating external sites
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 3 months after receiving the study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Pregnant or nursing female participants
- Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days following I-PDT treatment
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the I-PDT
- CT imaging suggestive of target tumor invasion into a major blood vessel (typically proximal to segmental vessels)
- Known hypersensitivity/allergy to porphyrin
- Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia
- Patients who have received 120 Gy total radiation dose delivered to a structure within 1 cm margin of tumor volume to be targeted by p-XRT and I-PDT
- Patients diagnosed with porphyria
- Patients with known allergy to eggs
- Patients unwilling or unable to follow protocol requirements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Phase I cohort 1 (I-PDT, EBUS)
Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial. |
Undergo CT
다른 이름들:
Ancillary studies Undergo blood and tissue sample collection
다른 이름들:
Ancillary studies
다른 이름들:
Undergo EBUS
다른 이름들:
Undergo I-PDT
다른 이름들:
Given IV
다른 이름들:
|
|
실험적: Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial. |
Undergo CT
다른 이름들:
Ancillary studies Undergo blood and tissue sample collection
다른 이름들:
Ancillary studies
다른 이름들:
Undergo EBUS
다른 이름들:
Undergo I-PDT
다른 이름들:
Given IV
다른 이름들:
Undergo palliative radiation therapy
다른 이름들:
Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.
다른 이름들:
|
|
실험적: Phase II (I-PDT, EBUS, palliative radiation therapy)
Phase II: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial. |
Undergo CT
다른 이름들:
Ancillary studies Undergo blood and tissue sample collection
다른 이름들:
Ancillary studies
다른 이름들:
Undergo EBUS
다른 이름들:
Undergo I-PDT
다른 이름들:
Undergo palliative radiation therapy
다른 이름들:
Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of >= grade 3 adverse events (Phase I)
기간: Within 30 days post interstitial photodynamic therapy (I-PDT)
|
Will will be associated with treatment related adverse events .grade 3 (with attribution of 'possible', 'probable' or 'definite'. Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0). |
Within 30 days post interstitial photodynamic therapy (I-PDT)
|
|
Overall tumor response (Phase II)
기간: At 12 weeks post I-PDT
|
Will be assessed by complete response (CR) or partial response (PR) defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) criteria. |
At 12 weeks post I-PDT
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall tumor response (Phase I)
기간: At 12 weeks post I-PDT
|
Will be assessed by CR or PR defined by the RECIST v 1.1 criteria. |
At 12 weeks post I-PDT
|
|
Quality of life (Phase I and II)
기간: At study enrollment, immediately prior to p-XRT and I-PDT, and at 4 and 12 weeks
|
Will be monitored using the Functional Assessment of Cancer Therapy-Lung. This 36 item self-reported quality of life questionnaire measures responses across six domains: physical well-being, social/family well-being, relationship with doctor, emotional well-being, functional well-being, and additional concerns. This scale was chosen because multiple studies support its validity and use in clinical trials of lung cancer. |
At study enrollment, immediately prior to p-XRT and I-PDT, and at 4 and 12 weeks
|
|
Functional lung capacity (Phase I and II)
기간: At study entry (baseline), 30 days and 12 weeks
|
Will be measured with the six-minute walk test. |
At study entry (baseline), 30 days and 12 weeks
|
|
Change in the therapeutic laser light transmission (Phase I and II)
기간: During the I-PDT
|
Will be measured with our light dosimetry system. |
During the I-PDT
|
|
Association between immune markers and tumor response (Phase I and II)
기간: Prior and 7-10 days after the I-PDT
|
will be measured with flow cytometry in fresh blood samples collected prior and 7-10 days after the I-PDT. |
Prior and 7-10 days after the I-PDT
|
|
Progression free survival (Phase I and II)
기간: Time from date of study treatment to the time of first observed disease progression (RECIST 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years
|
Will be summarized using standard Kaplan-Meier methods. |
Time from date of study treatment to the time of first observed disease progression (RECIST 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Nathaniel Ivanick, Roswell Park Cancer Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- I-3901323
- I-3901323 (기타 식별자: Roswell Park Cancer Institute)
- NCI-2024-01239 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- R01CA283547 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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