Overview

This trial is active, not recruiting.

Conditions lung cancer, metastatic cancer
Treatments chemotherapy, porfimer sodium, immunohistochemistry staining method, laboratory biomarker analysis, spectroscopy, therapeutic conventional surgery
Phase phase 2
Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborator National Cancer Institute (NCI)
Start date November 2004
End date July 2012
Trial size 9 participants
Trial identifier NCT00601848, CDR0000583050, UPCC-05503

Summary

RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy given during surgery works in treating patients with resectable non-small cell lung cancer that has spread to the pleura.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Toxicities of pleural photodynamic therapy
time frame:
Feasibility
time frame:
Overall survival
time frame:
Pleural progression-free survival
time frame:

Secondary Outcomes

Measure
Progression-free survival
time frame:
Photofrin® uptake in normal and tumor cells both directly and indirectly by optimal methods
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) - Must have clinical and/or pathological evidence of pleural spread - Primary tumor must be resectable as assessed by the attending thoracic surgeon - Patients who have received or are currently receiving two-to-four courses of standard front-line chemotherapy are eligible PATIENT CHARACTERISTICS: - Must be medically fit to tolerate surgery - No CTCAE v3.0 grade III-IV elevations in liver transaminases - Bilirubin ≤ 1.5 mg/dL - No known HIV infection - Not pregnant or nursing PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior treatment for NSCLC except pleurodesis or standard front-line chemotherapy - No prior pemetrexed disodium chemotherapy - No prior mantle radiotherapy - No concurrent chemotherapy or radiotherapy during the active study treatment period - Post-operative radiotherapy will be administered as clinically indicated

Additional Information

Official title A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread
Principal investigator Keith Cengel, MD, PhD
Description OBJECTIVES: Primary - To determine the overall survival rate of patients with non-small cell lung cancer (NSCLC) and malignant pleural spread treated with standard front-line chemotherapy followed by surgical resection and intra-operative porfimer sodium (Photofrin®)-mediated photodynamic therapy. - To determine the feasibility and toxicities of standard front-line chemotherapy followed by surgical resection and intra-operative Photofrin®-mediated photodynamic therapy in these patients. Secondary - To determine the progression-free survival and pleural progression-free survival of these patients. - To determine the absolute Photofrin® levels in tumor and normal tissues resected from these patients using spectrofluorometric methods. - To determine the tumor to normal tissue ratios of Photofrin® in these patients. - To measure the optical properties of tumor and normal tissues in situ. - To compare the Photofrin® concentration of tumor and normal tissues made with the in situ measurements to the measurements made with spectrofluorometric method. OUTLINE: This is a multicenter study. Patients receive 2-4 courses of standard front-line chemotherapy prior to surgery (if they have not completed the front-line chemotherapy). Patients receive porfimer sodium (Photofrin®) IV over 5-15 minutes. Approximately 24 hours after receiving porfimer sodium, patients undergo surgery to remove the primary tumor and the pleural disease to a thickness of 5 mm or less*. Patients then undergo intraoperative photodynamic therapy to the residual disease. Some patients may undergo postoperative radiotherapy to the mediastinum and/or surgical scar if clinically indicated. NOTE: *If the disease cannot be resected to less than 5 mm, PDT will not be delivered Tumor and normal tissue samples are obtained from the surgical specimen and examined prior to light delivery at the time of thoracotomy, and after light delivery. Tissue samples are analyzed for porphyrin levels using a spectrofluorometric assay of tissue specimens and an in situ optical method intra-operatively. Samples are also assessed for V-cadherin, markers for oxidative stress, markers associated with photosensitizer uptake, markers for angiogenesis, markers for hypoxia, activation of signaling pathway components (including EGFR, p38 MAPK, Akt, and p42/44 MAPK) via immunohistochemistry. After completion of study treatment, patients are followed periodically for 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.