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Brief Title: Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Official Title: An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
Study ID: NCT00441467
Brief Summary: Primary Objective: 1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate Secondary Objectives: 1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival 2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma Exploratory Objectives: 1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET 2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Premiere Oncology of Arizona, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
Stanford Cancer Center, Stanford, California, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Washington University School of Medicine, Division of Oncology, St. Louis, Missouri, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
St. Vincent's Comprehensive Cancer Center, New York, New York, United States
Name: Lee Cranmer, MD, PhD
Affiliation: University of Arizona
Role: PRINCIPAL_INVESTIGATOR
Name: David Mendelson, MD
Affiliation: Premiere Oncology of Arizona
Role: PRINCIPAL_INVESTIGATOR
Name: Douglas Adkins, MD
Affiliation: Washington University School of Medicine, Division of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Gina D'Amato, MD
Affiliation: H. Lee Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Gerald Rosen, MD
Affiliation: St. Vincent's Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Claire Verschraegen, MD
Affiliation: University of New Mexico Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Kristen Ganjoo, MD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR