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

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HPPH

endoscopic procedure

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HPPH

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor Response

Secondary Outcome Measures

Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale

Photosensitizer (HPPH) Concentration in Tumor

STAT3 Cross-links as Assessed by Western Blotting

Inflammation and Apoptosis as Assessed by Immunohistochemistry

Full Information

NCT ID

NCT00528775

First Posted

September 10, 2007

Last Updated

May 9, 2014

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00528775

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

drug cannot be prepared commercially

Study Start Date

August 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

March 2014 (Actual)

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

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.

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.

6. Conditions and Keywords

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

Lung Cancer

Keywords

adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPPH

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

HPPH

Intervention Description

4 mg/m2 IV

Intervention Type

Procedure

Intervention Name(s)

endoscopic procedure

Intervention Description

Treatment with 150 joules from laser

Primary Outcome Measure Information:

Title

Tumor Response

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale

Time Frame

2 months

Title

Photosensitizer (HPPH) Concentration in Tumor

Time Frame

2 months

Title

STAT3 Cross-links as Assessed by Western Blotting

Time Frame

2 months

Title

Inflammation and Apoptosis as Assessed by Immunohistochemistry

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd L. Demmy, 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 Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages

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