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

NCT00601848 | Terminated Phase 2 Results DMC

• 2 other identifiers: UPCC 05503CDR0000583050
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Toxicity Assessment of Pleural Photodynamic Therapy

  Toxicities of PDT as defined by CTCAE v4.0

  One year

• Overall Survival

  Subject survival post PDT

  5 years

• Pleural Progression-free Survival

  Amount of time from PDT to disease progression in pleura

  5 years

Secondary Outcomes (2)

• Progression-free Survival

  5 years

• Photofrin® Uptake

  90 days

Study Arms (1)

Photodynamic Therapy

EXPERIMENTAL

PDT

Drug: chemotherapy; Drug: porfimer sodium; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: spectroscopy; Procedure: therapeutic conventional surgery

Interventions

chemotherapy DRUG

Photodynamic Therapy

porfimer sodium DRUG

Photodynamic Therapy

immunohistochemistry staining method OTHER

Photodynamic Therapy

laboratory biomarker analysis OTHER

Photodynamic Therapy

spectroscopy PROCEDURE

Photodynamic Therapy

therapeutic conventional surgery PROCEDURE

Photodynamic Therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant

Interventions

Drug Therapy; Dihematoporphyrin Ether; Immunohistochemistry; Spectrum Analysis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Keith A Cengel, MD, PhD
• Organization: University of Pennsylvania

cengel@pennmedicine.upenn.edu

(215) 615-5312

Study Officials

• Keith Cengel, MD, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: January 28, 2008
• Study Start: November 1, 2004
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-04

Locations

US (1)