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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

Primary Purpose

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

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Light Dosimetry for Intranoperative Therapy

Photodynamic Therapy

Porfimer Sodium

About this trial

This is an interventional treatment trial for Malignant Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (porfimer sodium, IO-PDT)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free survival

The estimated distribution of progression free survival will be obtained using the Kaplan-Meier method. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

Overall survival (OS)

Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

Anti tumor response

Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence

Full Information

NCT ID

NCT03678350

First Posted

August 30, 2018

Last Updated

June 21, 2023

Sponsor

Roswell Park Cancer Institute

Collaborators

Lumeda,Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03678350

Brief Title

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

Official Title

Light Dosimetry for Intraoperative Photodynamic Therapy (IO-PDT) With Porfimer Sodium (Photofrin) in Patients With Malignant Mesothelioma or Non-Small Cell Lung Cancer (NSCLC), or Other Malignancies With Pleural Disease - Phase I Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

March 28, 2025 (Anticipated)

Study Completion Date

March 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

Lumeda,Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (porfimer sodium, IO-PDT)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Light Dosimetry for Intranoperative Therapy

Intervention Description

Undergo IO-PDT

Intervention Type

Procedure

Intervention Name(s)

Photodynamic Therapy

Other Intervention Name(s)

PDT, Photoradiation Therapy

Intervention Description

Undergo IO-PDT

Intervention Type

Drug

Intervention Name(s)

Porfimer Sodium

Other Intervention Name(s)

CL-184116, DHE, Dihematoporphyrin Ester, dihematoporphyrin ether, Photofrin II

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to 30 days

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Time Frame

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

Title

Overall survival (OS)

Description

Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

Time Frame

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

Title

Anti tumor response

Description

Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saikrishna Yendamuri

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ask RPCI

Phone

800-767-9355

ASKRPCI@roswellpark.org

First Name & Middle Initial & Last Name & Degree

Saikrishna S. Yendamuri

12. IPD Sharing Statement

Learn more about this trial

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

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