Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT00379665
First received: September 20, 2006
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy

Resource links provided by NLM:


Further study details as provided by Southwestern Regional Medical Center:

Primary Outcome Measures:
  • To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened. [ Time Frame: within 4 to 6 injections ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory symptoms due to occlusion to be assessed both before and after the procedure. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: October 2005
Study Completion Date: September 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
Drug: Cisplatin
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.

Detailed Description:

Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. Approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. A total of four to six injections are administered one week apart. Response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with inoperable lung carcinoma and/or recurrent disease.
  • Patients with symptomatic obstruction.
  • Occlusion or partial occlusion of bronchi.
  • Disease verified via bronchoscopy.
  • Patients with a least one endobronchial tumor, measuring at least 0.5 cm.
  • Patients between ages of 20 and 80 years.
  • Documented informed consent must be obtained.

Exclusion Criteria:

  • Patients without diagnosis confirmed by bronchoscopy.
  • Patients with endobronchial tumors measuring less than 0.5 cm.
  • Patients younger than 20 or older than 80 years.
  • Patients who do not sign informed consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379665

Locations
United States, Oklahoma
Cancer Treatment Centers of America ® Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133
Sponsors and Collaborators
Southwestern Regional Medical Center
Investigators
Principal Investigator: Daniel Nader, DO Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Southwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT00379665     History of Changes
Other Study ID Numbers: CTCT 05-01
Study First Received: September 20, 2006
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southwestern Regional Medical Center:
Lung
Chemotherapy
Cisplatin
Intratumoral
Bronchoscope
Brachytherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014