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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
feasibility and safety
The endpoint will be the proportion of toxicities attributed to administration of MnSOD plasmid liposome.
Yes
Ahmad Tarhini, MD
Principal Investigator
University of Pittsburgh Cancer Institute/Univeristy of Pittsburgh Medical Center, Cancer Centers
United States: Food and Drug Administration
01-054
NCT00618917
November 2005
September 2015
Name | Location |
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University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |