A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction

Plain English Summary

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction is a Phase 2 clinical trial sponsored by Roswell Park Cancer Institute studying Malignant Solid Neoplasm. This trial tests a new treatment combining light-activated therapy (photodynamic therapy) with radiation for lung airway blockages caused by cancer. It is for patients with inoperable tumors blocking their central airways, often from lung cancer or cancer that has spread to the lungs. Participation involves receiving radiation therapy followed by a light-sensitive drug and laser treatment, along with regular check-ups and sample collections. Alternative treatments may include surgery, stenting, laser therapy, or standard radiation with or without chemotherapy, depending on the specific situation. The trial aims to enroll 42 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of inoperable solid tumors causing airway obstruction. Patients must have tumors accessible for a specific laser treatment and be able to receive standard palliative radiation therapy. Individuals with certain blood count levels, blood clotting status, and generally good performance status (ECOG 0-3) may be eligible. Those who are pregnant, nursing, have specific eye conditions, severe allergies to the treatment components, or certain other medical conditions may not be able to participate. This trial is studying Malignant Solid Neoplasm, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will assess the safety of the new treatment by looking at severe side effects and its effectiveness by measuring how well the tumors respond, ultimately indicating if the The specific primary outcome measures are: Incidence of >= grade 3 adverse events (Phase I) (Within 30 days post interstitial photodynamic therapy (I-PDT)); Overall tumor response (Phase II) (At 12 weeks post I-PDT). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for effective treatments for malignant central airway obstruction, aiming to improve tumor control and survival without the severe side effects of high-dose radiat Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Malignant Solid Neoplasm, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in advanced cancer care, with potential to improve outcomes for patients with difficult-to-treat airway obstructions, signaling a potential new therapeutic Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of both radiation therapy and photodynamic therapy for your condition. Understand the schedule of treatments, including radiation sessions and the photodynamic therapy procedure, which involves a light-sensitive drug and laser. Be prepared for regular follow-up appointments, imaging scans, and potential blood tests to monitor your response and any side effects. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 42 participants

Interventions

• PROCEDURE: Biospecimen Collection — Undergo blood and tissue sample collection
• PROCEDURE: Computed Tomography — Undergo CT
• PROCEDURE: Endobronchial Ultrasound Bronchoscopy — Undergo EBUS
• PROCEDURE: Interstitial Photodynamic Therapy — Undergo I-PDT
• RADIATION: Palliative Radiation Therapy — Undergo palliative radiation therapy

Primary Outcomes

• Incidence of >= grade 3 adverse events (Phase I) (Within 30 days post interstitial photodynamic therapy (I-PDT))
• Overall tumor response (Phase II) (At 12 weeks post I-PDT)

Secondary Outcomes

• Overall tumor response (Phase I) (At 12 weeks post I-PDT)
• Quality of life (Phase I and II) (At study enrollment, immediately prior to p-XRT and I-PDT, and at 4 and 12 weeks)
• Functional lung capacity (Phase I and II) (At study entry (baseline), 30 days and 12 weeks)
• Change in the therapeutic laser light transmission (Phase I and II) (During the I-PDT)
• Association between immune markers and tumor response (Phase I and II) (Prior and 7-10 days after the I-PDT)

Full 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 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

Trial Locations

• Roswell Park Cancer Institute, Buffalo, New York, United States
• Abramson Cancer Center, Philadelphia, Pennsylvania, United States

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Malignant Solid Neoplasm
• Metastatic Cancer
• Esophageal Cancer
• Head and Neck Cancer
• Tracheal Tumors
• Bronchial Tumors
• Mediastinal Tumors
• Cancer of Unknown Primary
• Renal Cell Carcinoma Metastasis

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