55
Participants
Start Date
August 31, 2007
Primary Completion Date
January 31, 2012
Study Completion Date
February 29, 2012
Vitamin B12
"1 mg intramuscular injection~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.~Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
Folic Acid
"1 mg orally~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.~Administered daily throughout the study and for at least 30 days after last dose of pralatrexate."
Pralatrexate
Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or
Memorial Sloan-Kettering Cancer Center, New York
Columbia University Medical Center, New York
Emory University, Atlanta
Washington University School of Medicine, St Louis
City of Hope National Medical Center, Duarte
Stanford University School of Medicine, Redwood City
Fred Hutchinson Cancer Center, Seattle
Yale University School of Medicine, New Haven
Dana-Farber Cancer Institute, Boston
University of Texas MD Anderson Cancer Center, Houston
Lead Sponsor
Acrotech Biopharma Inc.
INDUSTRY