Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

Phase 3

Terminated

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Cisplatin

• Registration Number: NCT01487499
• Lead Sponsor: University of Florida

Brief Summary

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

1. 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

2. 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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2015-03-16
• Results First Submitted QC: 2015-03-16
• Results First Posted: 2015-03-25
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with limited stage SCLC	Cisplatin	Subjects with limited stage SCLC treated sequentially with cisplatin.

Primary Outcome Measures

Name	Time	Method
Solid Tumor Growth After Completion of Interventional Bronchoscopies	18 months	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

Name	Time	Method
Overall Survival	5 years	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.
Progression-free Survival	18 months

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States