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Phase I/II Study of Flavopiridol in Patients With Refractory or Recurrent Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Flavopiridol in Treating Patients With Refractory or Recurrent Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
Basic Trial Information
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Phase
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II, Phase I
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Biomarker/Laboratory analysis, Treatment
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Active
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18 and over
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NCI
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NCI-07-C-0081 NCI-P7040, 7844, NCT00445341
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Special Category:
NIH Clinical Center trial, NCI Web site featured trial Objectives Primary - Assess the response of patients with refractory or recurrent mantle cell lymphoma or diffuse large B-cell lymphoma treated with flavopiridol.
- Assess the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of this drug in these patients.
Secondary - Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetics with toxicity and the incidence of tumor lysis syndrome.
Entry Criteria Disease Characteristics:
- Pathologically confirmed refractory or recurrent mantle cell lymphoma OR diffuse large B-cell lymphoma (DLBCL), 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
- Measurable disease, defined as one of the following:
- Measurable disease in 2 dimensions
- Leukemic disease that can be quantified and followed
- Prior anthracycline-based treatment required for patients with DLBCL
- No active CNS lymphoma
Prior/Concurrent Therapy:
- See Disease Characteristics
- Recovered from all prior therapy
- More than 4 weeks since prior systemic cytotoxic therapy
- More than 4 weeks since prior experimental treatments
Patient Characteristics:
- ECOG performance status 0-2
- Absolute neutrophil count > 1,000/mm³ (independent of transfusions)
- Platelet count > 50,000/mm³ (independent of transfusions)
- WBC ≤ 100,000/mm³
- Creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
- ALT < 5 times upper limit of normal
- Bilirubin < 2 mg/dL (< 5 mg/dL in patients with Gilbert's syndrome, defined as > 80% unconjugated bilirubin)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
- Hepatitis B surface antigen negative
- No history of inflammatory bowel disease (unless inactive for ≥ 2 years)
Expected Enrollment 71A total of 71 patients will be accrued for this study. Outcomes Primary Outcome(s)Maximum tolerated dose (Phase I) Toxicity (Phase I) Response rate (complete response and partial response)
Secondary Outcome(s)Pharmacokinetics Incidence of tumor lysis syndrome
Outline This is a phase I, dose-escalation study followed by a phase II, open-label study. Patients enrolled in the phase II portion of the study are stratified according to disease (mantle cell lymphoma vs diffuse large B-cell lymphoma). - Phase II: Patients receive flavopiridol as in phase I at the MTD determined in phase I.
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). Samples are also analyzed for expression of Ki67 and by TUNEL staining. After completion of study treatment, patients are followed every 3-4 months until disease progression and then periodically thereafter.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research | | | Kieron Dunleavy, MD, Protocol chair | | | | Trial Sites
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U.S.A. |
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Maryland |
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Bethesda |
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| | | | | | | | NCI - Center for Cancer Research |
| | Clinical Trials Office - NCI - Center for Cancer Research | |
| | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office |
| | Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office | |
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Related Information Web site for additional information Featured trial article
Registry Information | | Official Title | | A Phase I/II Study of Flavopiridol in Relapsed or Refractory Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma (DLBCL) | | Trial Start Date | | 2007-02-01 | | Trial Completion Date | | 2009-11-17 (estimated) | | Registered in ClinicalTrials.gov | | NCT00445341 | | Date Submitted to PDQ | | 2007-01-19 | | Information Last Verified | | 2008-05-04 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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