Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer

NCT00526461 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000563238RPCI-I-05903
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage 0 non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity as measured by NCI CTC v2.0

  Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months

Secondary Outcomes (1)

• Tumor response

  At 4-6 weeks and 6 months

Study Arms (1)

PDT using HPPH

EXPERIMENTAL

Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.

Drug: HPPH

Interventions

HPPH DRUG

IV

PDT using HPPH

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma * May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology * Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria: * Lesion must be radiographically occult and not definable by conventional CT scan of the chest * Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy * Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma) * No evidence of major pulmonary vessel encasement on CT scan of the chest PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 4,000/mm\^3 * Prothrombin time ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 3.0 mg/dL * Creatinine ≤ 3.0 mg/dL * Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN * 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 or partial central airway obstruction from mucous/debris formation * Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment * No contraindications for bronchoscopy * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy * Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

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

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

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

Study Officials

• Samjot Dhillon, MD

  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: September 5, 2007
• First Posted: September 10, 2007
• Study Start: February 1, 2004
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

US (1)