Back to resultsIntratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Lung, Chemotherapy, Cisplatin, Intratumoral, Bronchoscope, Brachytherapy
Eligibility 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.
Sites / Locations
- Cancer Treatment Centers of America ® Southwestern Regional Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cisplatin
Arm Description
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
Outcomes
Primary Outcome Measures
To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.
Secondary Outcome Measures
Respiratory symptoms due to occlusion to be assessed both before and after the procedure.
Full Information
NCT ID
NCT00379665
First Posted
September 20, 2006
Last Updated
December 10, 2012
Sponsor
Southwestern Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00379665
Brief Title
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
Official Title
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southwestern Regional Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Lung, Chemotherapy, Cisplatin, Intratumoral, Bronchoscope, Brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cisplatin
Arm Type
Experimental
Arm Description
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Respiratory symptoms due to occlusion to be assessed both before and after the procedure.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Nader, DO
Organizational Affiliation
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Treatment Centers of America ® Southwestern Regional Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
13627755
Citation
BATEMAN JC. Palliation of cancer in human patients by maintenance therapy with NN'N"-triethylene thiophosphoramide and N-(3-oxapentamethylene)-N'N"-diethylene phosphoramide. Ann N Y Acad Sci. 1958 Apr 24;68(3):1057-71. doi: 10.1111/j.1749-6632.1958.tb42664.x. No abstract available.
Results Reference
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PubMed Identifier
9560102
Citation
Burris HA 3rd, Vogel CL, Castro D, Mishra L, Schwarz M, Spencer S, Oakes DD, Korey A, Orenberg EK. Intratumoral cisplatin/epinephrine-injectable gel as a palliative treatment for accessible solid tumors: a multicenter pilot study. Otolaryngol Head Neck Surg. 1998 Apr;118(4):496-503. doi: 10.1177/019459989811800412.
Results Reference
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PubMed Identifier
9786117
Citation
Monga SP, Wadleigh R, Adib H, Harmon JW, Berlin M, Mishra L. Endoscopic treatment of gastric cancer with intratumoral cisplatin/epinephrine injectable gel: a case report. Gastrointest Endosc. 1998 Oct;48(4):415-7. doi: 10.1016/s0016-5107(98)70014-8. No abstract available.
Results Reference
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PubMed Identifier
11870531
Citation
Vogl TJ, Engelmann K, Mack MG, Straub R, Zangos S, Eichler K, Hochmuth K, Orenberg E. CT-guided intratumoural administration of cisplatin/epinephrine gel for treatment of malignant liver tumours. Br J Cancer. 2002 Feb 12;86(4):524-9. doi: 10.1038/sj.bjc.6600116.
Results Reference
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PubMed Identifier
14607028
Citation
Celikoglu F, Celikoglu SI. Intratumoural chemotherapy with 5-fluorouracil for palliation of bronchial cancer in patients with severe airway obstruction. J Pharm Pharmacol. 2003 Oct;55(10):1441-8. doi: 10.1211/0022357021936.
Results Reference
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Citation
Celikoglu SI, Celikoglu F, Goldberg EP. Intratumoral cancer chemotherapy through a flexible bronchoscope. J Bronchol. 2004;11:260-265.
Results Reference
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PubMed Identifier
11848280
Citation
Goldberg EP, Hadba AR, Almond BA, Marotta JS. Intratumoral cancer chemotherapy and immunotherapy: opportunities for nonsystemic preoperative drug delivery. J Pharm Pharmacol. 2002 Feb;54(2):159-80. doi: 10.1211/0022357021778268.
Results Reference
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Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
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