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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

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ClinicalTrials.gov Identifier: NCT03678350
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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 or non-small cell lung cancer 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.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Non-Small Cell Lung Carcinoma Pleural Disorder Procedure: Light Dosimetry Procedure: Photodynamic Therapy Drug: Porfimer Sodium Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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) With Pleural Disease - Phase I Study
Estimated Study Start Date : December 30, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021


Arm Intervention/treatment
Experimental: 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.
Procedure: Light Dosimetry
Undergo IO-PDT

Procedure: Photodynamic Therapy
Undergo IO-PDT
Other Names:
  • PDT
  • Photoradiation Therapy

Drug: Porfimer Sodium
Given IV
Other Names:
  • CL-184116
  • DHE
  • Dihematoporphyrin Ester
  • dihematoporphyrin ether
  • Photofrin II




Primary Outcome Measures :
  1. Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 30 days ]
    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 :
  1. Progression-free survival [ 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 ]
    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.

  2. Overall survival (OS) [ Time Frame: From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years ]
    Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

  3. Anti tumor response [ Time Frame: Up to 2 years ]
    Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed mesothelioma or non-small cell lung cancer (NSCLC) 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 or legal representative 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678350


Locations
United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Ask RPCI    800-767-9355    ASKRPCI@roswellpark.org   
Principal Investigator: Saikrishna S. Yendamuri         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Saikrishna Yendamuri Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03678350     History of Changes
Other Study ID Numbers: I 62118
NCI-2018-01663 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 62118 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Dihematoporphyrin Ether
Hematoporphyrin Derivative
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents