Photodynamic Therapy for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Porphyria, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

19 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a treatment where a special drug is injected and then activated by a laser to shrink tumors in lung cancer patients whose cancer has spread. The goal is to see if this method can safely reduce tumor size.

Research Team

Nathaniel Ivanick, MD

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with lung cancer that's spread to nearby areas, who can undergo bronchoscopy under anesthesia. They must have a certain level of platelets in their blood, be able to use birth control if needed, and not be pregnant. People with recent radiotherapy, allergies to porphyrin, unstable health conditions or those unable to follow the study plan cannot join.

Inclusion Criteria

A specialist has confirmed that my airway can be treated with a procedure.

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

I am willing to undergo a specific low-dose radiation treatment as advised by my radiation oncologist.

Exclusion Criteria

My cancer has spread into the esophagus, confirmed by a special camera test.

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive I-PDT or PDT

I am not cleared for advanced bronchoscopy under general anesthesia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Porfimer sodium intravenously followed by EBUS-TBN guided interstitial photodynamic therapy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Visits at 4, 8, 12, and 24 weeks

Treatment Details

Interventions

• Porfimer Sodium
• Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy

Trial Overview The trial tests a treatment called interstitial photodynamic therapy (I-PDT) using Porfimer sodium on patients with advanced lung cancer. It involves injecting this drug and activating it with laser light inside the airways to shrink tumors.

Participant Groups

Group I: Treatment (porfimer sodium, EBUS, and photodynamic therapy) Experimental Treatment 2 Interventions

Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Pinnacle Biologics Inc.

Industry Sponsor

Trials

8

Recruited

1,000+

Simphotek Inc.

Collaborator

Trials

1

Recruited

20+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+