Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction
Verified date | May 2024 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 39 |
Est. completion date | July 1, 2029 |
Est. primary completion date | July 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 known allergy) 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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of >= grade 3 adverse events (Phase I) | 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) | |
Primary | Overall tumor response (Phase II) | 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 | |
Secondary | Overall tumor response (Phase I) | Will be assessed by CR or PR defined by the RECIST v 1.1 criteria. | At 12 weeks post I-PDT | |
Secondary | Quality of life (Phase I and II) | 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 | |
Secondary | Functional lung capacity (Phase I and II) | Will be measured with the six-minute walk test. | At study entry (baseline), 30 days and 12 weeks | |
Secondary | Change in the therapeutic laser light transmission (Phase I and II) | Will be measured with our light dosimetry system. | Up to 5 years | |
Secondary | Association between immune markers and tumor response (Phase I and II) | will be measured with flow cytometry in fresh blood samples collected prior and 30 days after the I-PDT. | Prior and 30 days after the I-PDT | |
Secondary | Progression free survival (Phase I and II) | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030427 -
Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT05660421 -
Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
|
Phase 2 | |
Suspended |
NCT04060849 -
Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
|
Phase 1 | |
Recruiting |
NCT06192875 -
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
|
||
Completed |
NCT04122118 -
Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor
|
N/A | |
Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03168737 -
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
|
Phase 1 | |
Active, not recruiting |
NCT06062901 -
An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT02444741 -
Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT04081298 -
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04555837 -
Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04983901 -
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
|
Phase 2 | |
Active, not recruiting |
NCT04602026 -
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
|
N/A | |
Recruiting |
NCT04871542 -
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
|
||
Active, not recruiting |
NCT04592250 -
Financial Toxicity in Cancer Patients
|
||
Recruiting |
NCT05112614 -
Role of Gut Microbiome in Cancer Therapy
|
||
Active, not recruiting |
NCT04296305 -
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
|
Phase 4 | |
Recruiting |
NCT05873608 -
Communication Issues in Patient and Provider Discussions of Immunotherapy
|
N/A | |
Recruiting |
NCT02464696 -
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
|
N/A |