NCT00025571

Brief Summary

RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 25, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

October 11, 2001

Last Update Submit

March 3, 2011

Conditions

Lung Cancer

Keywords

squamous cell lung cancerlarge cell lung canceradenocarcinoma of the lungstage I non-small cell lung cancerstage II non-small cell lung cancer

Interventions

HPPHDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed microinvasive or centrally obstructing non-small cell lung cancer * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% OR * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 3.0 mg/dL * Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) * SGOT no greater than 3 times ULN * PT no greater than 1.5 times ULN Renal: * Creatinine no greater than 3.0 mg/dL Pulmonary: * No severe chronic obstructive pulmonary disease that would preclude study Other: * Not pregnant * Fertile patients must use effective contraception * No contraindications to bronchoscopy * No porphyria * No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic therapy for lung cancer allowed Chemotherapy: * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * Prior endocrine therapy for lung cancer allowed Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent external beam radiotherapy Surgery: * No concurrent surgery Other: * Prior therapy for lung cancer allowed

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

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsAdenocarcinoma of LungCarcinoma, Non-Small-Cell Lung

Interventions

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

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Gregory M. Loewen, DO, FCCP

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

June 25, 2003

Study Start

June 1, 2001

Primary Completion

October 1, 2002

Study Completion

October 1, 2004

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)