Clinical trial NCT02106559: Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
Official title: A Pilot Study of Pleural Photodynamic Therapy for Patients With Pleural Malignancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stage III Malignant Mesothelioma
Stage IIIB Non-small Cell Lung Cancer
Stage IV Malignant Mesothelioma
Stage IV Non-small Cell Lung Cancer
Keywords: Pleural Photodynamic Therapy
Pleural Malignancy
PDT
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.

Detailed description: PRIMARY OBJECTIVES; I. To determine the feasibility and toxicities of incorporating surgical resection and intra-operative Photofrin (porfimer sodium)-mediated photodynamic therapy in patients (pts) with malignant pleural mesothelioma (MPM) or non-small cell lung cancer (NSCLC) with pleural spread.

SECONDARY OBJECTIVES:

I. To determine the overall survival rate of pts with NSCLC and pleural spread treated with standard frontline chemotherapy followed by surgical resection and intra-operative Photofrin-mediated photodynamic therapy.

II. To determine the overall survival rate of pts with MPM after radical pleurectomy and intraoperative Photofrin-mediated photodynamic therapy (PDT).

III. To determine the progression-free survival and pleural progression-free survival in the above mentioned pts.

IV. To determine the absolute Photofrin levels in tumor and normal tissues resected from pts using spectrofluorometric assay. Photofrin levels in tumor to normal tissue ratios will be determined.

OUTLINE:

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative PDT to the pleural space.

After completion of treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of NSCLC or MPM; pts must have clinical and/or pathological evidence of pleural spread or stage III/IV MPM
* Pts with NSCLC who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
* Assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
* Assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
* All studies required for evaluation will be performed within 8 weeks of Photofrin administration
* Pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
* ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION
* Pts undergoing extrapleural pneumonectomy without PDT for MPM or stage IV (M1A) NSCLC (after American Joint Committee on Cancer \[AJCC\] staging change 2010) or stage IIIB (before staging change) with malignant pleural effusion treated at Ohio State University (OSU) from 2005-2012
* Historical control data will be derived from patient medical records at the Ohio State University Medical Center (OSUMC)

Exclusion Criteria:

* Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 4.0) or a bilirubin in excess of 1.5 mg/dl
* Pts who are medically unfit to tolerate surgery
* Pts with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) disease (routine testing is not needed if not clinical indicated)
* Pregnant or lactating pts
* Prior treatment for NSCLC except for pleurodesis and/or standard frontline chemotherapy
* Pts who have received prior mantle or extensive mediastinal radiation

Primary outcomes:
measure: Number of patients who received the entire multi-modality regimen
timeFrame: Up to 2 years
measure: Incidence of grade 4 or greater toxicity in the post-operative period as graded by the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0
timeFrame: Up to 90 days post surgery
Secondary outcomes:
measure: Overall survival
timeFrame: Time from study entry (start of chemotherapy) to death due to any cause or last patient contact, assessed up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Time from study entry to first documented progression (any type, intrapleural, distant, locoregional) or death due to any cause, assessed up to 2 years
measure: Pleural progression-free survival (PPFS)
timeFrame: Time from surgery/PDT to first documented intrapleural progression or death from any cause, assessed up to 2 years
measure: Porfimer sodium uptake defined as the ratio of the porfimer sodium concentration in tumor tissue to normal tissue (i.e. skin) using spectrofluorometric assay
timeFrame: After surgery
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Meng Welliver
role: PRINCIPAL_INVESTIGATOR
References: