Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

Study Overview
=================
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.

Official Title
-----------------
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Cisplatin


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with limited stage SCLC<br>Subjects with limited stage SCLC treated sequentially with cisplatin. | Drug: Cisplatin<br>* 40 mg in 40 mL of normal saline for each of 4 bronchoscopies<br>|
| No Intervention: Historical Controls<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | 18 months | 
| 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. | 5 years |