Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery

NCT03678350 | Completed Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: I 62118NCI-2018-01663
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating participants with malignant mesothelioma , non-small cell lung cancer or any other malignancy with pleural disease undergoing surgery. Light dosimetry measures the amount of laser light given during photodynamic therapy. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to light. The activated drug may kill tumor cells. Using light dosimetry for intraoperative photodynamic therapy may help doctors estimate how much light is delivered during photodynamic therapy and decide if the treatment should be stopped or continued.

Conditions

Malignant Mesothelioma; Non-Small Cell Lung Carcinoma; Pleural Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

  The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.

  Up to 30 days

Secondary Outcomes (3)

• Progression-free survival

  From time of surgery + photodynamic therapy (PDT) or, until start of a new treatment, disease progression or death (whichever occurs first), assessed up to 3 years

• Overall survival (OS)

  From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years

• Anti tumor response

  Up to 2 years

Study Arms (1)

Treatment (porfimer sodium, IO-PDT)

EXPERIMENTAL

Participants receive porfimer sodium IV over 3-5 minutes and receive IO-PDT via a light dosimetry system 24-48 hours later.

Device: Light Dosimetry for Intranoperative Therapy; Procedure: Photodynamic Therapy; Drug: Porfimer Sodium

Interventions

Light Dosimetry for Intranoperative Therapy DEVICE

Undergo IO-PDT

Treatment (porfimer sodium, IO-PDT)

Photodynamic Therapy PROCEDURE

Undergo IO-PDT

Also known as: PDT, Photoradiation Therapy

Treatment (porfimer sodium, IO-PDT)

Porfimer Sodium DRUG

Given IV

Also known as: CL-184116, DHE, Dihematoporphyrin Ester, dihematoporphyrin ether, Photofrin II

Treatment (porfimer sodium, IO-PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed malignant mesothelioma , non-small cell lung cancer (NSCLC) or other malignancies with pleural disease without distant disease.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2.
• Subjects 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 6 months after surgery. 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.
• The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• White blood cell (WBC) \< 4,000.
• Platelet count \< 100,000.
• Total serum bilirubin \> 2 mg/dL.
• Serum creatinine \> 2 mg/dL.
• Alkaline phosphatase \> 3 times the upper normal limit.
• Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 3 times the upper normal limit.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or nursing female subjects.
• Unwilling or unable to follow protocol requirements.
• Any condition which in the investigator?s opinion deems the subject an unsuitable candidate to receive porfimer sodium.
• Received an investigational agent within 30 days prior to enrollment.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Lumeda,Inc.: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant; Carcinoma, Non-Small-Cell Lung; Pleural Diseases

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Phototherapy; Dihematoporphyrin Ether; Trioxsalen

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Saikrishna Yendamuri

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 19, 2018
• Study Start: September 17, 2021
• Primary Completion: November 13, 2023
• Study Completion: October 9, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)