Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

This study is currently recruiting participants.

Verified March 2013 by University of Florida

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT01487499

First received: December 1, 2011

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2011

Last Updated Date

March 19, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Solid tumor growth after completion of interventional bronchoscopies [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01487499 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-free survival [ Time Frame: evaluate survival rates for 18 months ] [ Designated as safety issue: Yes ]
The RECIST system will be used to grade response to therapy
Overall survival [ Time Frame: for 5 years ] [ Designated as safety issue: Yes ]
follow subjects for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.

Original Secondary Outcome Measures ^ICMJE

Progression-free survival [ Time Frame: evaluate survival rates for 18 months ] [ Designated as safety issue: Yes ]
The RECIST systemn will be used to grade response to therapy
Overall survival [ Time Frame: for 5 years ] [ Designated as safety issue: Yes ]
follow subjects for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

Official Title ^ICMJE

Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer

Brief Summary

This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:

to implement a prospective clinical trial to test the feasibility and efficacy of intralesional chemotherapy as consolidative therapy immediately following standard systemic chemotherapy and radiation therapy for patients with limited stage SCLC by comparing tumor growth and survival rates of the treatment group and compare the outcomes to historical controls
to implement a prospective clinical trial to test the feasibility and efficacy as measured by tumor growth and survival rates of intralesional chemotherapy for patients with recurrent SCLC after standard treatment.

Detailed Description

Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome measurements of tumor growth and survival will be compared to subjects receiving standard of care treatment only.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Cisplatin

40 mg in 40 mL of normal saline for each of 4 bronchoscopies

Study Arm (s)

Experimental: patients with limited stage SCLC
Subjects with limited stage SCLC treated sequentially with cisplatin.

Intervention: Drug: Cisplatin
No Intervention: Historical Controls
No intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: Competent adult English speaking subjects

With limited stage SCLC who have completed standard of care treatment who are responders with no evidence of disseminated disease other than CNS metastasis,
With recurrent disseminated SCLC after standard of care treatment with symptoms related to central tumor obstruction,
With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously treated with intratumoral cisplatin

Exclusion Criteria:

Subjects who do not meet the inclusion criteria
Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michael Jantz, MD	(866) 229-6312	michael.jantz@medicine.ufl.edu
Contact: Pamela Schreck, RN MSN	352-294-5195	pschreck@ufl.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01487499

Other Study ID Numbers ^ICMJE

SCLC

Has Data Monitoring Committee

Yes

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael A. Jantz, MD

University of Florida

Information Provided By

University of Florida

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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