Clinical trial NCT00601848: Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura
Official title: A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Metastatic Cancer
Keywords: stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
malignant pleural effusion
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Toxicity Assessment of Pleural Photodynamic Therapy
timeFrame: One year
measure: Overall Survival
timeFrame: 5 years
measure: Pleural Progression-free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 5 years
measure: Photofrin® Uptake
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Keith Cengel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: