Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

University of Florida

Status and phase: Terminated; Phase 3

Conditions: Small Cell Lung Cancer

Treatments: Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01487499

SCLC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

patients with limited stage SCLC

Experimental group

Description:

Subjects with limited stage SCLC treated sequentially with cisplatin.

Treatment:

Drug: Cisplatin

Historical Controls

No Intervention group

Description:

No intervention