Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00528775
First received: September 10, 2007
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.

PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.


Condition Intervention Phase
Lung Cancer
Drug: HPPH
Procedure: endoscopic procedure
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Advanced Obstructing Endobronchial Lung Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Palliation of symptoms as assessed by the pulmonary symptom scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Photosensitizer (HPPH) concentration in tumor [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • STAT3 cross-links as assessed by western blotting [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Inflammation and apoptosis as assessed by immunohistochemistry [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2007
Study Completion Date: March 2014
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPPH
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
Drug: HPPH
4 mg/m2 IV
Procedure: endoscopic procedure
Treatment with 150 joules from laser

Detailed Description:

OBJECTIVES:

Primary

  • To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.

Secondary

  • To determine palliation of symptoms in patients treated with this regimen.
  • To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.
  • To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.
  • To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.

OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH.

Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.

After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Biopsy confirmed advanced obstructing endobronchial non-small cell lung cancer

    • May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
  • Ineligible for or refused surgical resection
  • Local endobronchial recurrence after prior surgical resection, radiotherapy, or chemotherapy allowed
  • No evidence of tumor encasement of major pulmonary vessels on CT scan of the chest

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
  • WBC ≥ 4,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Prothrombin time < 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.0 mg/dL
  • Creatinine ≤ 2.0 mg/dL
  • Alkaline phosphatase (hepatic) ≤ 3 times ULN
  • SGOT ≤ 3 times ULN
  • No contraindications for bronchoscopy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after the completion of study treatment
  • Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous/debris formation at the site of treatment
  • Patients who cannot breathe due to complete upper airway obstruction and who need emergency treatment to open the airway are not eligible
  • No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
  • No severe chronic obstructive pulmonary disease that, in the opinion of the investigator, would preclude multiple bronchoscopies
  • No partial central airway obstruction from mucous/debris formation
  • No high-grade upper airway obstruction of the trachea

PRIOR CONCURRENT THERAPY:

  • Any type of prior therapy (e.g., chemotherapy or radiotherapy) for lung cancer allowed
  • At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528775

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Todd L. Demmy, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00528775     History of Changes
Other Study ID Numbers: CDR0000563948, RPCI-I-98707
Study First Received: September 10, 2007
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the lung
large cell lung cancer
squamous cell lung cancer
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014