Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

NCT01487499 | Terminated Phase 3 Results DMC

• 1 other identifier: SCLC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:

1. 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. 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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (2)

• Progression-free Survival

  18 months

• Overall Survival

  5 years

Study Arms (2)

patients with limited stage SCLC

EXPERIMENTAL

Subjects with limited stage SCLC treated sequentially with cisplatin.

Drug: Cisplatin

Historical Controls

NO INTERVENTION

No intervention

Interventions

Cisplatin DRUG

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

patients with limited stage SCLC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Michael A. Jantz, MD
• Organization: University of Florida

michael.jantz@medicine.ufl.edu

352-273-8737

Study Officials

• Michael A. Jantz, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 11, 2015
• Results First Posted: March 25, 2015

Record last verified: 2015-05

Locations

US (1)