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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00601848
First received: January 25, 2008
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicities of pleural photodynamic therapy [ Designated as safety issue: Yes ]
  • Feasibility [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Pleural progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Photofrin® uptake in normal and tumor cells both directly and indirectly by optimal methods [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2004
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601848

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Keith Cengel, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00601848     History of Changes
Other Study ID Numbers: CDR0000583050, UPCC-05503
Study First Received: January 25, 2008
Last Updated: July 7, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
malignant pleural effusion

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014