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Brief Title: Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma
Official Title: An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma
Study ID: NCT00435578
Brief Summary: The primary objectives of this study are: 1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate 2. To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC The secondary objectives are: 1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival 2. To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM) The exploratory objectives of this trial are: 1. To evaluate the effect of glufosfamide on lung cancer symptoms 2. To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
California Cancer Center, Greenbrae, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Name: Gerold Bepler, MD, PhD
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: John C Ruckdeschel, MD
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Peter D Eisenberg, MD
Affiliation: California Cancer Center
Role: PRINCIPAL_INVESTIGATOR