Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01487499
First received: December 1, 2011
Last updated: May 13, 2014
Last verified: May 2014

December 1, 2011
May 13, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01487499 on ClinicalTrials.gov Archive Site
  • 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.
  • Progression-free survival [ Time Frame: evaluate survival rates for 18 months ] [ Designated as safety issue: Yes ]
    The RECIST systemn 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.
Not Provided
Not Provided
 
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
Drug: Cisplatin
40 mg in 40 mL of normal saline for each of 4 bronchoscopies
  • Experimental: patients with limited stage SCLC
    Subjects with limited stage SCLC treated sequentially with cisplatin.
    Intervention: Drug: Cisplatin
  • No Intervention: Historical Controls
    No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Michael Jantz, MD (866) 229-6312 michael.jantz@medicine.ufl.edu
Contact: Pamela Schreck, RN MSN 352-294-5195 pschreck@ufl.edu
United States
 
NCT01487499
SCLC
Yes
University of Florida
University of Florida
Not Provided
Principal Investigator: Michael A. Jantz, MD University of Florida
University of Florida
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP