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

May 9, 2014 updated by: Roswell Park Cancer Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor Response
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale
Time Frame: 2 months
2 months
Photosensitizer (HPPH) Concentration in Tumor
Time Frame: 2 months
2 months
STAT3 Cross-links as Assessed by Western Blotting
Time Frame: 2 months
2 months
Inflammation and Apoptosis as Assessed by Immunohistochemistry
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (ESTIMATE)

September 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000563948
  • RPCI-I-98707 (OTHER: Roswell Park Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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