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

NCT00379665 | Completed Phase 2

• 1 other identifier: CTCT 05-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung; Chemotherapy; Cisplatin; Intratumoral; Bronchoscope; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.

  within 4 to 6 injections

Secondary Outcomes (1)

• Respiratory symptoms due to occlusion to be assessed both before and after the procedure.

  3 years

Study Arms (1)

Cisplatin

EXPERIMENTAL

1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.

Drug: Cisplatin

Interventions

Cisplatin DRUG

1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.

Cisplatin

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwestern Regional Medical Center: lead

Study Sites (1)

Cancer Treatment Centers of America ® Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

Location

Related Publications (7)

• 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.

  PMID: 13627755 BACKGROUND

• 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.

  PMID: 9560102 BACKGROUND

• 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.

  PMID: 9786117 BACKGROUND

• 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.

  PMID: 11870531 BACKGROUND

• 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.

  PMID: 14607028 BACKGROUND

• Celikoglu SI, Celikoglu F, Goldberg EP. Intratumoral cancer chemotherapy through a flexible bronchoscope. J Bronchol. 2004;11:260-265.

  BACKGROUND

• 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.

  PMID: 11848280 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Daniel Nader, DO

  Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 22, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (1)