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Light Dosimetry for Photodynamic Therapy with Porfimer Sodium in Treating Patients with Malignant Mesothelioma or Non-small Cell Lung Cancer with Pleural Disease Undergoing Surgery

Trial Status: Approved

This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating patients 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.

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 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.
  • Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
  • 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.
  • The following special populations are excluded from this study: * Cognitively impaired adults/adults with impaired decision-making capacity * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women

New York

Buffalo
Roswell Park Cancer Institute
Status: APPROVED
Contact: Saikrishna S. Yendamuri
Phone: 716-845-8675

PRIMARY OBJECTIVE:

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:

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

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Roswell Park Cancer Institute

Principal Investigator
Saikrishna S. Yendamuri

  • Primary ID I 62118
  • Secondary IDs NCI-2018-01663
  • Clinicaltrials.gov ID NCT03678350