A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction
Roswell Park Cancer Institute
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.
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 relatio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and tissue sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureEndobronchial Ultrasound Bronchoscopy
Undergo EBUS
- ProcedureInterstitial Photodynamic Therapy
Undergo I-PDT
- RadiationPalliative Radiation Therapy
Undergo palliative radiation therapy
- OtherPhysical Performance Testing
Ancillary studies
- OtherQuestionnaire Administration
Locations (2)
- Roswell Park Cancer InstituteBuffalo, New York
- Abramson Cancer CenterPhiladelphia, Pennsylvania