NCT00984243

Brief Summary

This study is being done to determine whether a substance called hematoporphyrin can be used to treat tumors in various locations in the body when used in association with a laser. Hematoporphyrin is a substance that is taken up by cancerous cells. When these cells are exposed to the energy emitted by a laser source, chemical reactions occur in the cell and cause the cells to die. It is hoped that this treatment method may be able to selectively destroy malignant cells without damaging surrounding healthy tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Feb 1994

Longer than P75 for not_applicable lung-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1994

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

12.7 years

First QC Date

December 24, 2007

Last Update Submit

November 13, 2012

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery.

    3 years

Secondary Outcomes (6)

  • Morbidity,overall mortality and lung cancer mortality.

    3 years

  • Rate of subsequent lung cancer.

    3 years

  • Relative cost of PDT and surgery.

    3 years

  • Change in pulmonary function over time.

    3 years

  • Effect on quality of life.

    3 years

  • +1 more secondary outcomes

Study Arms (1)

Photodynamic Therapy

EXPERIMENTAL

PHOTODYNAMIC THERAPY (PDT)

Procedure: PHOTODYNAMIC THERAPY (PDT)

Interventions

PHOTODYNAMIC THERAPY (PDT)PROCEDURE

Photodynamic Procedure: Photofrin II will be injected at a dosage of 2 mm/Kg intravenously. Laser treatment will take place 40-50 hours later. An argon-dye or an excimer-dye laser tuned to 620-630 nm will be used. It is anticipated that a microlens fiber will be used in almost all cases, but a cylinder-diffusing fiber can be used to treat lesions in segmental bronchi if needed. Argon-dye laser: Power settings 200 milliwatt (mW) microlens and 400 mW for cylinder Excimer laser: 4 milliJoules (mJoules)/pulse at 30 hertz for the microlens Energy density: Argon-dye laser: 200-300 Joules/cm\^2 Excimer-dye laser: 100-200 Joules/cm\^2

Photodynamic Therapy

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient less than 75 years of age.
  • Squamous cell lung cancer proven by biopsy or repeated Brushings obtained from the same location at separate bronchoscopies.
  • Occult lung cancer by chest roentgenogram and CT scan If CT scan is abnormal, mediastinoscopy is negative.
  • Cancer is bronchoscopically superficial as defined in section IV, E.
  • Estimated size less than 1 cm diameter on the surface of the bronchus with the surface area of 0.7 to 1.0 cm2.
  • Location in the trachea, main stem bronChi, lobar bronchi, segmental bronchi, or subsegmental bronchi.
  • Medical condition permits surgery: cardiovascular status is satisfactory for operation and postoperative FEVl is predicted to be greater than 0.75 liter.
  • Patients will complete quality of life questionnaire and a spirometry which will include forced expiratory volume in 1 second (FEVl) and forced vital capacity (FVC).
  • On bronchoscopic biopsy, the carcinoma is entirely in situ or shows no more than 2 mm of microinvasion.
  • The characteristics of the mucosa. may include paleness, opacity, loss of luster, roughness, micro-granularity.
  • The mucosal folds may demonstrate lack of clarity. thickening, disappearance.
  • There may be small nodular protrusion of tumor into the lumen
  • The peripheral extent of tumor invasion can be confirmed endoscopically.

You may not qualify if:

  • A medical disease which excludes surgery as an option
  • A postoperative FEVl predicted to be less than 0.75 liter
  • A previous carcinoma or other malignancy not curatively treated
  • The presence of simultaneous lung cancers
  • CT scan of the chest shows thickening of the bronchial wall or extension beyond the bronchial wall in the area of the cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Eric S. Edell, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 24, 2007

First Posted

September 25, 2009

Study Start

February 1, 1994

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

US(1)