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
  Purpose

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 13, 2014
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

ClinicalTrials.gov processed this record on August 28, 2014