15
Participants
Start Date
November 30, 1999
Primary Completion Date
July 31, 2007
Study Completion Date
October 31, 2009
doxorubicin hydrochloride
To be dosed at 75 mg/m2 i.v. push every 4 weeks for 4 cycles. This treatment is optional and will not be used on all subjects.
ifosfamide and mesna
2 gm / m2 ifosfamide mixed in 1000 cc D5W infused continuously over 24 hours daily for 6 days (144 hours); total ifosfamide dose 12 gm/ m2. For the day infusion only MESNA (sodium 2-mercapto-ethanesulphonate) is mixed with ifosfamide as above and given at 2.5 gm / m2 / 24 hours.
hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator
Patients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90.
radiation therapy
External beam megavoltage (≥ 4 MV) beams will be used at SSD, SAD ≥ 70 cm at a dose rate of \> 100 cGy/min. Fraction sizes of 180 cGy will be used 5 times per weeks in a continuous course. Total dose will be 45 Gy + 10%, consistent with sites being treated.
Duke Cancer Institute, Durham
National Cancer Institute (NCI)
NIH
Mark Dewhirst
OTHER