Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Todd L. Demmy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000563948

NCT ID:

NCT00528775

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263