Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTID

Outcome Description:

Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

Samjot Dhillon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 05903

NCT ID:

NCT01668823

Start Date:

February 2004

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263