Photodynamic Therapy in Treating Patients With Lung Cancer

NCT01668823 | Completed Phase 1 DMC

• 2 other identifiers: I 05903NCI-2010-02114
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• MTID

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

  Up to 2 years

• Systemic toxicity according to NCI Common Toxicity Criteria version 2

  Up to 6 months

• PDT-related normal tissue toxicity

  Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.

  Up to 6 months

Secondary Outcomes (1)

• Objective tumor response

  Up to 6 months

Study Arms (1)

Treatment (PDT using HPPH)

EXPERIMENTAL

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.

Drug: HPPH; Drug: photodynamic therapy; Procedure: therapeutic bronchoscopy

Interventions

HPPH DRUG

Given IV

Also known as: Photochlor

Treatment (PDT using HPPH)

photodynamic therapy DRUG

Undergo photodynamic therapy with HPPH

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Treatment (PDT using HPPH)

therapeutic bronchoscopy PROCEDURE

Undergo therapeutic bronchoscopy for endoscopic debridement

Treatment (PDT using HPPH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Samjot Dhillon

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: February 1, 2004
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (1)