Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with limited stage SCLC

Subjects with limited stage SCLC treated sequentially with cisplatin.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

40 mg in 40 mL of normal saline for each of 4 bronchoscopies

Historical Controls

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cisplatin

40 mg in 40 mL of normal saline for each of 4 bronchoscopies

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy

Eligible Sex

ALL

Accepts Healthy Volunteers

No