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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00601848
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 97
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Metastatic Cancer	Drug: chemotherapy; Drug: porfimer sodium; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: spectroscopy; Procedure: therapeutic conventional surgery	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Photodynamic Therapy PDT	Drug: chemotherapy; Drug: porfimer sodium; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: spectroscopy; Procedure: therapeutic conventional surgery

Outcome Measures

Primary Outcome Measures

1. Toxicity Assessment of Pleural Photodynamic Therapy [One year]

   Toxicities of PDT as defined by CTCAE v4.0

2. Overall Survival [5 years]

   Subject survival post PDT

3. Pleural Progression-free Survival [5 years]

   Amount of time from PDT to disease progression in pleura

Secondary Outcome Measures

1. Progression-free Survival [5 years]

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

2. Photofrin® Uptake [90 days]

   Measured uptake of PDT drug

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Keith Cengel, MD, PhD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00601848
• Other Study ID Numbers: UPCC 05503; CDR0000583050
• First Posted: Jan 28, 2008
• Last Update Posted: Nov 24, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; malignant pleural effusion
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Dihematoporphyrin Ether; Trioxsalen

Study Results

Participant Flow

Arm/Group Title	Photodynamic Therapy
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Period Title: Overall Study
STARTED	9
COMPLETED	0
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 33.3%
>=65 years	6 66.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71 (10.35)
Sex: Female, Male (Count of Participants)
Female	4 44.4%
Male	5 55.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 11.1%
White	7 77.8%
More than one race	0 0%
Unknown or Not Reported	1 11.1%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Toxicity Assessment of Pleural Photodynamic Therapy
Description	Toxicities of PDT as defined by CTCAE v4.0
Time Frame	One year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Measure Participants	0

2. Primary Outcome

Title	Overall Survival
Description	Subject survival post PDT
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Measure Participants	0

3. Primary Outcome

Title	Pleural Progression-free Survival
Description	Amount of time from PDT to disease progression in pleura
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Measure Participants	0

4. Secondary Outcome

Title	Progression-free Survival
Description	Amount of time from PDT to disease progression at any site in the body
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Measure Participants	0

5. Secondary Outcome

Title	Photofrin® Uptake
Description	Measured uptake of PDT drug
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
Measure Participants	0

Adverse Events

Arm/Group Title	Single Arm
Arm/Group Description	PDT chemotherapy porfimer sodium immunohistochemistry staining method laboratory biomarker analysis spectroscopy therapeutic conventional surgery
All Cause Mortality
	Single Arm
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Serious Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.