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

NCT ID: NCT03678350

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2026-10-13

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To demonstrate that our light dosimetry system is safe and effective in guiding intraoperative photodynamic therapy with porfimer sodium (Photofrin).

SECONDARY OBJECTIVES:

I. To evaluate progression free survival (PFS) and overall survival (OS). II. To examine the relationship between immune biomarkers and response.

OUTLINE:

Participants receive porfimer sodium intravenously (IV) over 3-5 minutes and receive intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system 24-48 hours later.

After conclusion of study treatment, participants are followed up at 30 days, within 4 weeks from surgery and PDT and every 6 months for 2 years.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (porfimer sodium, IO-PDT)

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

Group Type: EXPERIMENTAL

Light Dosimetry for Intranoperative Therapy

Intervention Type: DEVICE

Undergo IO-PDT

Photodynamic Therapy

Intervention Type: PROCEDURE

Undergo IO-PDT

Porfimer Sodium

Intervention Type: DRUG

Given IV

Interventions

Light Dosimetry for Intranoperative Therapy

Undergo IO-PDT

Intervention Type: DEVICE

Photodynamic Therapy

Undergo IO-PDT

Intervention Type: PROCEDURE

Porfimer Sodium

Given IV

Intervention Type: DRUG

Other Intervention Names

PDT; Photoradiation Therapy; CL-184116; DHE; Dihematoporphyrin Ester; dihematoporphyrin ether; Photofrin II

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumeda,Inc.

UNKNOWN

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saikrishna Yendamuri

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2018-01663

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 62118

Identifier Type: OTHER

Identifier Source: secondary_id

I 62118

Identifier Type: -

Identifier Source: org_study_id