Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer Clinical Trial

— SCLC  

Official title:

Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01487499
• Other study ID #: SCLC
• Status: Terminated
• Phase: Phase 3
• First received: December 1, 2011
• Last updated: May 15, 2015
• Start date: December 2011
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Cisplatin
40 mg in 40 mL of normal saline for each of 4 bronchoscopies

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Progression-free Survival		18 months	Yes
Secondary	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	Yes