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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00618917 |
This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung cancer (NSCLC).
Condition | Intervention | Phase |
---|---|---|
Radiation-Induced Esophageal Toxicity |
Genetic: MnSOD |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Chemotherapy (Paclitaxel and Carboplatin)and Thoracic Radiotherapy With Swallowed Manganese Superoxide Dismutase (MnSOD) Plasmid Liposome Protection in Patients With Locally Advanced Stage III Non-Small Cell Lung Cancer: A Phase I-II Study |
Estimated Enrollment: | 45 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung cancer (NSCLC). Phase I of the study will assess the feasibility and safety of MnSOD PL by dose escalation in 3 cohorts of 3 chemoradiotherapy subjects each (Cohort1 = 0.3 mg/dose, Cohort2 = 3 mg/dose, Cohort3 = 30 mg/dose). The highest dose completed (as determined by toxicity monitoring for 8 weeks from initial treatment) will be the starting dose for Phase II. Phase II will examine the efficacy of MnSOD PL by assessing the incidence of Grade 3 or 4 esophagitis in 27 additional chemoradiotherapy subjects. Incidence of esophageal toxicity, as well as clinical response to the combination of chemoradiotherapy with MnSOD PL are the outcomes of interest.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Joel Greenberger, MD | University of Pittsburgh Cancer Institute/Univeristy of Pittsburgh Medical Center, Cancer Centers |
Responsible Party: | Univeristy of Pittsburgh Cancer Institute ( Athanassios Argiris, MD ) |
Study ID Numbers: | 01-054 |
Study First Received: | February 6, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00618917 |
Health Authority: | United States: Food and Drug Administration |
NSCLC lung cancer chemotherapy radiation therapy radiation toxicity |
Thoracic Neoplasms Non-small cell lung cancer Esophageal disorder Gastrointestinal Diseases Carboplatin Carcinoma Esophagitis Digestive System Diseases |
Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Esophageal Diseases Manganese Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |