Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01487499
First received: December 1, 2011
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:
- 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
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: Cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- Solid tumor growth after completion of interventional bronchoscopies [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]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:
- Progression-free survival [ Time Frame: evaluate survival rates for 18 months ] [ Designated as safety issue: Yes ]The RECIST system will be used to grade response to therapy
- Overall survival [ Time Frame: for 5 years ] [ Designated as safety issue: Yes ]follow subjects for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: patients with limited stage SCLC
Subjects with limited stage SCLC treated sequentially with cisplatin.
|
Drug: Cisplatin
40 mg in 40 mL of normal saline for each of 4 bronchoscopies
|
|
No Intervention: Historical Controls
No intervention
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487499
Contacts
| Contact: Michael Jantz, MD | (866) 229-6312 | michael.jantz@medicine.ufl.edu |
| Contact: Pamela Schreck, RN MSN | 352-294-5195 | pschreck@ufl.edu |
Locations
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Michael A. Jantz, MD 866-229-6312 michael.jantz@medicine.ufl.edu | |
| Contact: Pamela J. Schreck, RN MSN (866) 229-6312 pschreck@ufl.edu | |
| Principal Investigator: Michael Jantz, MD | |
| Sub-Investigator: Frederic Kaye, MD | |
| Sub-Investigator: Eugene Goldberg, PhD | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Michael A. Jantz, MD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01487499 History of Changes |
| Other Study ID Numbers: | SCLC |
| Study First Received: | December 1, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013