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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HPPH

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage 0 non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PDT using HPPH

Arm Description

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.

Outcomes

Primary Outcome Measures

Toxicity as measured by NCI CTC v2.0

Secondary Outcome Measures

Tumor response

Full Information

NCT ID

NCT00526461

First Posted

September 5, 2007

Last Updated

August 2, 2023

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00526461

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

stage 0 non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large 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

PDT using HPPH

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

HPPH

Intervention Description

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Tumor response

Time Frame

At 4-6 weeks and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samjot Dhillon, MD

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

14263-0001

Country

United States

12. IPD Sharing Statement

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

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