Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00014066
First received: April 10, 2001
Last updated: February 4, 2013
Last verified: February 2013
  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
Radiation: brachytherapy
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: March 1993
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00014066     History of Changes
Other Study ID Numbers: DS 92-40, RPCI-DS-92-40, NCI-V97-1190
Study First Received: April 10, 2001
Last Updated: February 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Carcinoma, Bronchogenic
Lung Neoplasms
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Hematoporphyrins
Hematoporphyrin Derivative
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014