Status:
COMPLETED
Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: Mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) are aggressive subtypes of non-Hodgkin lymphoma. Flavopiridol is an investigational drug that works differently from ...
Detailed Description
Background: Flavopiridol is a synthetic N-methylpiperidinyl, chlorophenyl flavone compound that targets a number of different cellular pathways and processes. It works through several different mech...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- Previously treated mantle cell lymphoma or diffuse large B-cell lymphoma (to include mediastinal (thymic) large B-cell lymphoma; transformed large B-cell lymphoma; follicular grade IIIB large B-cell lymphoma; intravascular large B-cell lymphoma).
- Confirmed pathological diagnosis at the National Cancer Institute, National Institutes of Health (NIH).
- Recurrent measurable disease (measurable disease in 2 dimensions or leukemic disease which can be quantified and followed).
- Prior anthracycline-based treatment for patients with diffuse large B-cell lymphoma (DLBCL).
- Age greater than 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance 2 or better.
- Major organ function: absolute neutrophil count (ANC) greater than 1000/mcL, Platelet greater than 50,000/mcL, Creatinine less than 1.5 mg/dL or creatinine clearance greater than 60 mL/min; serum glutamic pyruvic transaminase (SGPT) less than 5 x upper limit of normal; bilirubin less than 2 mg/dL (total) except less than 5 mg/dL in patients with Gilbert's syndrome as defined by greater than 80% unconjugated. ANC and platelet requirements must be met independent of transfusion.
- Informed consent and willingness to use contraception by both men and women.
- Both male and female patients must be willing to use adequate contraception (to include effective barrier methods of contraception) or to completely abstain from heterosexual intercourse while on protocol treatment.
- EXCLUSION CRITERIA:
- Pregnant or nursing because of an unknown potential for teratogenic or abortifacient effects.
- Human immunodeficiency virus (HIV) serology negative. HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with flavopiridol. Additionally, the biology of HIV associated DLBCL's is often quite different from HIV negative disease due to involvement of Epstein Barr virus (EBV).
- Hepatitis B surface antigen negative.
- Active central nervous system (CNS) lymphoma. These patients have a poor prognosis and because they frequently develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
- History of inflammatory bowel disease unless this has been inactive for a period of 2 or more years.
- Recovery from toxicity of prior therapy to a grade 1 or less.
- Systemic cytotoxic or experimental treatments within 4 weeks of treatment.
- White blood cell (WBC) greater than 100,000 cells/mcL.
Exclusion
Key Trial Info
Start Date :
November 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00445341
Start Date
November 27 2006
End Date
October 18 2012
Last Update
January 30 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892