Photodynamic Therapy in Treating Patients With Lung Cancer

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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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

MTID

Secondary Outcome

 Objective tumor response

Condition

Adenocarcinoma of the Lung

Intervention

HPPH

Study Arms / Comparison Groups

 Treatment (PDT using HPPH)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

17

Start Date

February 2004

Completion Date

June 2014

Primary Completion Date

June 2013

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Samjot Dhillon, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01668823

Organization ID

I 05903

Secondary IDs

NCI-2010-02114

Responsible Party

Sponsor

Study Sponsor

Roswell Park Cancer Institute

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Samjot Dhillon, Principal Investigator, Roswell Park Cancer Institute


Verification Date

July 2014