Trial Title:
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
NCT ID:
NCT06306638
Condition:
Malignant Solid Neoplasm
Conditions: Official terms:
Airway Obstruction
Verteporfin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and tissue sample collection
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Endobronchial Ultrasound Bronchoscopy
Description:
Undergo EBUS
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
EBUS
Other name:
Endobronchial Ultrasound
Intervention type:
Procedure
Intervention name:
Interstitial Photodynamic Therapy
Description:
Undergo I-PDT
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
I-PDT
Other name:
Interstitial Illumination Photodynamic Therapy
Intervention type:
Radiation
Intervention name:
Palliative Radiation Therapy
Description:
Undergo palliative radiation therapy
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
Palliative Radiotherapy
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Ancillary studies
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Intervention type:
Drug
Intervention name:
Verteporfin
Description:
Given IV
Arm group label:
Phase I cohort 1 (I-PDT, EBUS)
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Other name:
Benzoporphyrin Derivative Monoacid Ring A
Other name:
BPD-MA
Other name:
Visudyne
Intervention type:
Device
Intervention name:
Laser: ML7710-PDT
Description:
Measuring tumor response
Arm group label:
Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
Arm group label:
Phase II (I-PDT, EBUS, palliative radiation therapy)
Other name:
Fiber-coupled diode laser: ML7710-PDT
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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 CT (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 or legal representative 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 diagnosed with porphyria
- Patients with known allergy to eggs
- Patients unwilling or unable to follow protocol requirements
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nathaniel Ivanick
Phone:
716-845-5873
Email:
Nathaniel.Ivanick@RoswellPark.org
Investigator:
Last name:
Nathaniel Ivanick
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
October 1, 2029
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Modulight, Inc.
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06306638
