Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages

NCT00528775 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000563948RPCI-I-98707
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: 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, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages. PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  6 months

Secondary Outcomes (4)

• Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale

  2 months

• Photosensitizer (HPPH) Concentration in Tumor

  2 months

• STAT3 Cross-links as Assessed by Western Blotting

  2 months

• Inflammation and Apoptosis as Assessed by Immunohistochemistry

  2 months

Study Arms (1)

HPPH

EXPERIMENTAL

Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.

Drug: HPPH; Procedure: endoscopic procedure

Interventions

HPPH DRUG

4 mg/m2 IV

HPPH

endoscopic procedure PROCEDURE

Treatment with 150 joules from laser

HPPH

Eligibility Criteria

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

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

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
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

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

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Todd L. Demmy, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Study Start: August 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2014
• Last Updated: June 10, 2014
• Results First Posted: June 10, 2014

Record last verified: 2014-05

Locations

US (1)