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Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer

This study has been completed.

Sponsored by: Roswell Park Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014066
  Purpose

RATIONALE: Photodynamic therapy uses light and drugs that make cnacer cells more sensitive to light to kill tumor cells. Brachytherapy uses radiation to damage tumor cells. Photodynamic therapy combined with brachytherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy plus brachytherapy in treating patients with recurrent lung cancer that is blocking the lung passages.


Condition Intervention Phase
Lung Cancer
Drug: hematoporphyrin derivative
Procedure: brachytherapy
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Hematoporphyrin derivative   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Study of Photodynamic Therapy (PDT) Combined With High Dose Rate (HDR) Brachytherapy for Patients With Obstructive Bronchogenic Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 1993

Detailed Description:

OBJECTIVES: I. Determine the feasibility, toxicity, and effectiveness of combination therapy with Photofrin PDT and HDT brachytherapy in patients with endobronchial obstructions from lung cancer.

OUTLINE: This is not a randomized study. Photofrin solution is administered slowly as a bolus injection over 3-5 minutes on day 1. Bronchoscopy is performed under general anesthesia 48 hours after Photofrin injection. Light is transmitted from the laser to the tumor via quartz fiber optics (interstitial or surface PDT). Another bronchoscopy is performed 48 hours after PDT treatment to clean out any tissue debris left after PDT treatment. HDR brachytherapy is performed using prescribed dose of radiation for 5-10 minutes to designated positions. Repeat bronchoscopy is performed 3-4 weeks post HDR brachytherapy and a second HDR brachytherapy treatment may be given. Patients are followed every 3 months until death, or for 5 years.

PROJECTED ACCRUAL: 16 patients will be entered over 1.5 years.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed small cell or non-small cell primary lung cancer with symptomatic endobronchial lesion(s) partially or totally obstructing airway distal to the carina and accessible by endoscopy Recurrent disease following prior therapy and/or be ineligible for, or refuse, alternative standard therapy such as: Surgery External radiation therapy Chemotherapy High grade obstruction necessitating more rapid aeration and palliation than standard therapy can provide No evidence of encasement or extension of the tumor to the right or left major pulmonary vessels on CT of the chest No tumor involvement at trachea or carina

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times the upper limit of normal SGOT/SGPT less than 2 times the upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant Adequate method of contraception required of all fertile patients Female fertile patients must have normal serum beta HCG Not eligible for standard therapy and/or other protocol therapy No hypersensitivity to DHE or other porphyrins Not concurrent photosensitizing drugs such as: Tetracycline Doxorubicin No contraindications to general anesthesia, including EKG abnormalities suggestive of acute ischemia

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy within 3 weeks prior to study entry No doxorubicin within 8 weeks prior to study entry Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy dose no higher than 75 Gy to proposed bronchial segment allowed No concurrent external brain radiation therapy Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014066

Locations
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators
Roswell Park Cancer Institute

Investigators
Study Chair:     Gregory M. Loewen, DO, FCCP     Roswell Park Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065448, RPCI-DS-92-40, NCI-V97-1190
First Received:   April 10, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00014066
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer  
recurrent non-small cell lung cancer  
limited stage small cell lung cancer  
recurrent small cell lung cancer  
stage 0 non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Hematoporphyrin Derivative
Hematoporphyrins
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Recurrence
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Photosensitizing Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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