Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGCisplatin
40 mg in 40 mL of normal saline for each of 4 bronchoscopies
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 18 months | — |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Limited Stage SCLC Subjects with limited stage SCLC treated sequentially with cisplatin.
Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Patients With Limited Stage SCLC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 18 months
Population: No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis.
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.
Time frame: 5 years
Secondary
Progression-free Survival
Time frame: 18 months