CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0604 (clinicaltrials.gov NCT No: NCT00967369)
Title:A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients with Relapsed/Refractory Classical Hodgkin Lymphoma
Principal Investigator:Michelle A. Fanale
Treatment Agent:Bortezomib; Carboplatin; Etoposide; Ifosfamide; MESNA
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if bortezomib when given
in combination with ifosfamide, carboplatin, and etoposide (a routine
chemotherapy combination called ICE) can help to control Hodgkin's lymphoma
better than ICE when given alone. The safety of this drug combination will
also be studied.

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Disease Group:Lymphoma
Phase of Study:Phase II
Treatment Agents:Bortezomib
Carboplatin
Etoposide
Ifosfamide
MESNA
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Patients will be hospitalized for chemotherapy every 2 to 4 weeks for up to a
maximum of 6 cycles. It is anticipated that patients will remain in the
hospital for on average 4 to 6 days.
Supported By:Millennium Pharmaceuticals - Supporter only (Investigator-initiated study)
Return Visit:Screening, Pre-Treatment -3 days prior to each cycle 1 through 3, Day 1- Day 5
of cycle 1 through 3, Intercycle between each cycle (weekly), Response
Assessment, Follow up every 4 months for 2 years
Home Care:None


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Physician Name:Michelle A. Fanale
Dept:Lymphoma/Myeloma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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