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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00377104 |
RATIONALE: Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: alvocidib Procedure: cytogenetic analysis Procedure: immunoenzyme technique Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: pharmacological study Procedure: polymorphism analysis Procedure: protein expression analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Dose-Escalation Study of Flavopiridol (NSC 649890) Administered as a 30 Minute Loading Dose Followed by a 4-Hour Infusion in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Following Cytoreduction With Chemotherapy |
Estimated Enrollment: | 24 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive flavopiridol IV over 30 minutes (loading dose), followed by flavopiridol IV over 4 hours on days 1, 8, and 15. Treatment repeats every 5 weeks for up to 2 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. A total of 12 patients are treated at the MTD (i.e., recommended phase II dose).
Patients undergo blood collection at baseline and periodically during study for pharmacokinetic and cytokine studies (levels of tumor necrosis factor-alpha, interleukin [IL]-6, -11, and -16) by enzyme-linked immunosorbent assay (ELISA). Interphase cytogenetics, p53 mutational status, p53/ATM function, V_H mutational status, zeta-chain-associated protein kinase 70 (ZAP-70) overexpression, and single nucleotide polymorphisms are also examined.
After completion of study treatment, patients are followed at 2 months and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Must have received 1-3 prior therapies for CLL
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No other concurrent hormonal therapy except for the following:
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com |
Study Chair: | John C. Byrd, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000501975, OSU-05116, OSU-IRB-2006C0031 |
Study First Received: | September 13, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00377104 |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
Chronic lymphocytic leukemia Flavopiridol Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Growth Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |