Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00526461
First received: September 5, 2007
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: HPPH
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Toxicity as measured by NCI CTC v2.0 [ Time Frame: Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: At 4-6 weeks and 6 months ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: February 2004
Study Completion Date: April 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDT using HPPH
Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
Drug: HPPH
IV

Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma.
  • To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients.

Secondary

  • To study tumor response in these patients.

OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light 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 at that time.

After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and 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 carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma

    • May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
  • Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria:

    • Lesion must be radiographically occult and not definable by conventional CT scan of the chest
    • Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy
    • Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma)
  • No evidence of major pulmonary vessel encasement on CT scan of the chest

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 4,000/mm^3
  • Prothrombin time ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 3.0 mg/dL
  • Creatinine ≤ 3.0 mg/dL
  • Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN
  • 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 or partial central airway obstruction from mucous/debris formation
  • Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment
  • No contraindications for bronchoscopy
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
  • Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer
  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: NCT00526461

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: Samjot Dhillon, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00526461     History of Changes
Other Study ID Numbers: CDR0000563238, RPCI-I-05903
Study First Received: September 5, 2007
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
stage 0 non-small cell lung cancer
adenocarcinoma of the lung
squamous cell lung cancer
large 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 September 16, 2014