Clofazimine Use in the Long Term Treatment of Leprosy, Phase III
Principal Investigator: Deborah K. Riley, MD
Collaborators: Joseph M. Kontra, MD; Neil A. Greene, MD; Lucyann Sciandra, DO
Sponsor: National Hansen’s Disease Program; M. Patricia Joyce, MD
Objective: To use the drug Clofazimine in the treatment of leprosy. The drug is no longer available through pharmacies and can only be obtained through this protocol.
A Non-randomized, Prospective Study of IVC Filter Retrieval Out to 12 Weeks without Interim Filter Manipulation Utilizing the Günther Tulip Vena Cava Filter
Principal Investigator: John Briguglio, MD
Collaborators: Frederick Beyer, III, MD; Edward Chory, MD; Frederick Heinle, MD; Stacey Mazzacco, MD; Paul Newman, MD; David Winand, MD; Edgar Fearnow, MD; Robert Gress, MD; Robert Latshaw, MD; Paul A. Leslie, MD; Leigh Shuman, MD
Sponsor: Cook Incorporated
Objective: The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be safely removed without interim manipulation out to 12 weeks post-implantation when implanted in patients for the prevention of pulmonary thromboembolism.
NSABP PROTOCOL B-39: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
Principal Investigator: Jeffrey S. Eshleman, MD
Collaborators: None
Sponsor: National Surgical Adjuvant Breast and Bowel Project
Objective: The objective of this study is to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer. B-39/0413 will compare overall survival, recurrence-free survival, and distant disease-free survival between women receiving PBI and women receiving WBI. The study will also look at quality of life (QOL) issues related to cosmesis, fatigue, treatment-related symptoms, and perceived convenience of care. Acute and late toxicities between the two radiation therapy regimens will also be compared.