Trial record 1 of 1 for:    00526461
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Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00526461
First received: September 5, 2007
Last updated: September 9, 2013
Last verified: September 2013

September 5, 2007
September 9, 2013
February 2004
July 2014   (final data collection date for primary outcome measure)
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 ]
Toxicity as measured by NCI CTC v2.0
Complete list of historical versions of study NCT00526461 on ClinicalTrials.gov Archive Site
Tumor response [ Time Frame: At 4-6 weeks and 6 months ] [ Designated as safety issue: No ]
Tumor response
Not Provided
Not Provided
 
Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: HPPH
IV
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.
Intervention: Drug: HPPH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00526461
CDR0000563238, RPCI-I-05903
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Samjot Dhillon, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP