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Photodynamic Therapy in Treating Patients With Lung Cancer

Primary Purpose

Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPPH
photodynamic therapy
therapeutic bronchoscopy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer
  • Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
  • Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy
  • Patients must have no contraindications for bronchoscopy
  • Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
  • Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group [ECOG] 0-2)
  • Patients must sign an Informed Consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
  • Patients with underlying lung disease must be judged (by the principal investigator) able to with stand mucous/debris formation at the site of treatment
  • Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be radiographically occult and not definable by conventional computed tomography (CT) of the chest; the lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on lung imaging fluorescence endoscope (LIFE) bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond cartilage on histopathology; the lesion may, however, be invasive through the basement membrane (microinvasive carcinoma)

Exclusion Criteria:

  • Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
  • White blood cells (WBC) < 4000
  • Platelet count < 100,000
  • Prothrombin time exceeding 1.5 times the upper normal limit
  • Total serum bilirubin > 3.0 mg/dl
  • Serum creatinine > 3.0 mg/dl
  • Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
  • Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
  • Any evidence of worsening pulmonary symptoms or COPD exacerbation
  • Evidence of major pulmonary vessel encasement on CT scan of the chest
  • Myocardial infarction (Ml) or unstable angina in the previous 6 months

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (PDT using HPPH)

Arm Description

Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.

Outcomes

Primary Outcome Measures

MTID
Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
Systemic toxicity according to NCI Common Toxicity Criteria version 2
PDT-related normal tissue toxicity
Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.

Secondary Outcome Measures

Objective tumor response

Full Information

First Posted
August 16, 2012
Last Updated
July 30, 2014
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01668823
Brief Title
Photodynamic Therapy in Treating Patients With Lung Cancer
Official Title
A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2014 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed.
Detailed Description
PRIMARY OBJECTIVES: I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma. SECONDARY OBJECTIVES: I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma. OUTLINE: This is a dose-escalation study. Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5. After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage 0 Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (PDT using HPPH)
Arm Type
Experimental
Arm Description
Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
Intervention Type
Drug
Intervention Name(s)
HPPH
Other Intervention Name(s)
Photochlor
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
photodynamic therapy
Other Intervention Name(s)
Light Infusion Therapy™, PDT, therapy, photodynamic
Intervention Description
Undergo photodynamic therapy with HPPH
Intervention Type
Procedure
Intervention Name(s)
therapeutic bronchoscopy
Intervention Description
Undergo therapeutic bronchoscopy for endoscopic debridement
Primary Outcome Measure Information:
Title
MTID
Description
Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
Time Frame
Up to 2 years
Title
Systemic toxicity according to NCI Common Toxicity Criteria version 2
Time Frame
Up to 6 months
Title
PDT-related normal tissue toxicity
Description
Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Objective tumor response
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy Patients must have no contraindications for bronchoscopy Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group [ECOG] 0-2) Patients must sign an Informed Consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB) Patients with underlying lung disease must be judged (by the principal investigator) able to with stand mucous/debris formation at the site of treatment Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be radiographically occult and not definable by conventional computed tomography (CT) of the chest; the lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on lung imaging fluorescence endoscope (LIFE) bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond cartilage on histopathology; the lesion may, however, be invasive through the basement membrane (microinvasive carcinoma) Exclusion Criteria: Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds White blood cells (WBC) < 4000 Platelet count < 100,000 Prothrombin time exceeding 1.5 times the upper normal limit Total serum bilirubin > 3.0 mg/dl Serum creatinine > 3.0 mg/dl Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation Any evidence of worsening pulmonary symptoms or COPD exacerbation Evidence of major pulmonary vessel encasement on CT scan of the chest Myocardial infarction (Ml) or unstable angina in the previous 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samjot Dhillon
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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Photodynamic Therapy in Treating Patients With Lung Cancer

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