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Investigator(s):
Kieron Dunleavy, M.D. Principal Investigator Phone: 301-435-1007 dunleavk@mail.nih.gov	Wyndham H. Wilson, M.D., Ph.D. Protocol Chair Phone: 301-435-2415 wilsonw@mail.nih.gov
Referral Contact(s):
Therese White, R.N., M.S.N. Research Nurse Phone: 301-402-5886 whiteth@mail.nih.gov

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Primary Eligibility:

• Pathologically confirmed mantle cell lymphoma or diffuse large B-cell lymphoma, including any of the following:
• Mediastinal (thymic) large B-cell lymphoma
• Transformed large B-cell lymphoma
• Follicular grade IIIB large B-cell lymphoma
• Intravascular large B-cell lymphoma
• Previously treated disease; recovered from all prior therapy
• Prior anthracycline-based treatment for patients with DLBCL
• Recurrent measurable disease
• Age > 18 years
• No active CNS lymphoma
• HIV serology negative
• Hepatitis B surface antigen negative
• ECOG Performance Status 0-2
• WBC ≤ 100,000/mm³
• Absolute neutrophil count > 1,000/mm³ (independent of transfusions)
• Platelet count > 50,000/mm³ (independent of transfusions)
• Creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
• ALT < 5 times upper limit of normal (ULN)
• Bilirubin < 2 mg/dL (< 5 mg/dL in patients with Gilbert’s syndrome defined as > 80% unconjugated)
• No history of inflammatory bowel disease (unless inactive ≥ 2 years)
• Not pregnant or nursing

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Treatment Plan:

This is a Phase I dose-escalation study followed by a Phase II portion.

Phase I

• Patients receive flavopiridol IV over 4.5 hours once a week for 4 weeks
• Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
• Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined
• The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity

Phase II

• Patients are stratified according to disease (mantle cell lymphoma vs. diffuse large B-cell lymphoma)
• Patients receive flavopiridol at the MTD determined in Phase I
• Patients receive flavopiridol IV over 4.5 hours once a week for 4 weeks, as in the Phase I portion
• Blood samples are collected periodically for pharmacokinetic analysis and research studies (including microarray analysis, proteomic analysis, and immunohistochemistry of markers such as BCL-2, p53, MUM-1, BCL-6, MIB-1, and CD10)
• After completion of study treatment, patients are followed every 3-4 months until disease progression and then periodically thereafter

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/18/08
Updated: 5/23/07