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Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura

A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00601848
Enrollment
9
Registered
2008-01-28
Start date
2004-11-30
Completion date
2012-12-31
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Metastatic Cancer

Keywords

stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, malignant pleural effusion

Brief 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.

Detailed 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.

Interventions

DRUGchemotherapy
DRUGporfimer sodium
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
PROCEDUREspectroscopy
PROCEDUREtherapeutic conventional surgery

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Toxicity Assessment of Pleural Photodynamic TherapyOne yearToxicities of PDT as defined by CTCAE v4.0
Overall Survival5 yearsSubject survival post PDT
Pleural Progression-free Survival5 yearsAmount of time from PDT to disease progression in pleura

Secondary

MeasureTime frameDescription
Progression-free Survival5 yearsAmount of time from PDT to disease progression at any site in the body
Photofrin® Uptake90 daysMeasured uptake of PDT drug

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Arm
PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
9
Total9

Baseline characteristics

CharacteristicSingle Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
6 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
Age, Continuous71 years
STANDARD_DEVIATION 10.35
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
7 Participants
Region of Enrollment
United States
9 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 9
other
Total, other adverse events
0 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

Overall Survival

Subject survival post PDT

Time frame: 5 years

Population: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Primary

Pleural Progression-free Survival

Amount of time from PDT to disease progression in pleura

Time frame: 5 years

Population: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Primary

Toxicity Assessment of Pleural Photodynamic Therapy

Toxicities of PDT as defined by CTCAE v4.0

Time frame: One year

Population: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Secondary

Photofrin® Uptake

Measured uptake of PDT drug

Time frame: 90 days

Population: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Secondary

Progression-free Survival

Amount of time from PDT to disease progression at any site in the body

Time frame: 5 years

Population: The study was terminated. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026