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

NCT ID: NCT00379665

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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Lung Chemotherapy Cisplatin Intratumoral Bronchoscope Brachytherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cisplatin

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

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

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

Interventions

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Cisplatin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwestern Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Nader, DO

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Cancer Treatment Centers of America ® Southwestern Regional Medical Center

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 13627755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9560102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9786117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11870531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14607028 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11848280 (View on PubMed)

Other Identifiers

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CTCT 05-01

Identifier Type: -

Identifier Source: org_study_id