Back to resultsBronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC) (SCLC)
Primary Purpose
Small Cell Lung Cancer
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
patients with limited stage SCLC
Historical Controls
Arm Description
Subjects with limited stage SCLC treated sequentially with cisplatin.
No intervention
Outcomes
Primary Outcome Measures
Solid Tumor Growth After Completion of Interventional Bronchoscopies
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.
Secondary Outcome Measures
Progression-free Survival
Overall Survival
Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01487499
Brief Title
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
Acronym
SCLC
Official Title
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll adequate number of participants
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with limited stage SCLC
Arm Type
Experimental
Arm Description
Subjects with limited stage SCLC treated sequentially with cisplatin.
Arm Title
Historical Controls
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
40 mg in 40 mL of normal saline for each of 4 bronchoscopies
Primary Outcome Measure Information:
Title
Solid Tumor Growth After Completion of Interventional Bronchoscopies
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
18 months
Title
Overall Survival
Description
Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Jantz, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
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