Intersticiální fotodynamická terapie po paliativní radioterapii při léčbě pacientů s inoperabilní maligní obstrukcí centrálních dýchacích cest
Studie fáze I/II intersticiální fotodynamické terapie po paliativní radioterapii u pacientů s inoperabilní maligní obstrukcí centrálních dýchacích cest
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: ASKRPCI@RoswellPark.org
- Telefonní číslo: 1-877-275-7724
- E-mail: askrpci@roswellpark.org
Studijní místa
-
-
New York
-
Buffalo, New York, Spojené státy, 14263
- Nábor
- Roswell Park Cancer Institute
-
Kontakt:
- Nathaniel Ivanick
- Telefonní číslo: 716-845-5873
- E-mail: Nathaniel.Ivanick@RoswellPark.org
-
Vrchní vyšetřovatel:
- Nathaniel Ivanick
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- Nábor
- Abramson Cancer Center
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: 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
Ostatní jména:
Ancillary studies Undergo blood and tissue sample collection
Ostatní jména:
Ancillary studies
Ostatní jména:
Undergo EBUS
Ostatní jména:
Undergo I-PDT
Ostatní jména:
Given IV
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Ancillary studies Undergo blood and tissue sample collection
Ostatní jména:
Ancillary studies
Ostatní jména:
Undergo EBUS
Ostatní jména:
Undergo I-PDT
Ostatní jména:
Given IV
Ostatní jména:
Undergo palliative radiation therapy
Ostatní jména:
Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Ancillary studies Undergo blood and tissue sample collection
Ostatní jména:
Ancillary studies
Ostatní jména:
Undergo EBUS
Ostatní jména:
Undergo I-PDT
Ostatní jména:
Undergo palliative radiation therapy
Ostatní jména:
Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of >= grade 3 adverse events (Phase I)
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall tumor response (Phase I)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Nathaniel Ivanick, Roswell Park Cancer Institute
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, fúzované kroužek
- Vyšetřovací techniky
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Azoly
- Polycyklické sloučeniny
- Diagnostické techniky, respirační systém
- Heterocyklické sloučeniny, 4 nebo více prstenů
- Pyrroly
- Makrocyklické sloučeniny
- Diagnostické techniky, kardiovaskulární
- Testy funkce srdce
- Testy respiračních funkcí
- Ergometrie
- Porfyriny
- Tetrapyrroly
- Verteporfin
- Manipulace se vzorkem
- Cvičební test
Další identifikační čísla studie
Další identifikační čísla studie
- I-3901323
- I-3901323 (Jiný identifikátor: Roswell Park Cancer Institute)
- NCI-2024-01239 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- R01CA283547 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .