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A Phase I/II Study of SB-743921 in Patients with Non-Hodgkin's Lymphoma
[Protocol 07-083]
- Full Title :
- A PHASE I-II STUDY TO DETERMINE THE SAFETY, PHARMACOKINETICS AND POTENTIAL EFFICACY OF INTRAVENOUS ADMINISTRATION OF SB-743921 ON DAYS 1 AND 15 OF A 28 DAY DOSING SCHEDULE IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA
- Purpose :
SB-743921 is an investigational drug that inhibits a protein cells need to divide. By blocking cell division, SB-743921 interrupts the cell growth process, leading to cell death. Since cancer cells depend on cell division to grow, they should be particularly sensitive to this drug.
The purpose of the phase I portion of this study is to determine highest dose of SB-743921 that can be given safely either alone or with G-CSF (a drug that increases the amount of certain white blood cells) in patients with Hodgkin's disease or non-Hodgkin's lymphoma (NHL) that has not responded to standard treatment. Researchers will assess the effectiveness of SB-743921 in the phase II portion of the study.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of Hodgkin's disease or NHL that has returned despite prior treatment with standard therapies. Patients with B-cell lymphomas must have had prior treatment with rituximab.
- At least 30 days must have passed since completion of prior therapy and entry into the study. For patients in the phase II portion of the study, at least 2 months must have passed since last receiving rituximab or alemtuzumab and entry into the study.
- Patients participating in the phase I portion of the study may not have had prior radioimmunotherapy.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.
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