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Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
This study has been completed.
Study NCT00058240   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2003   Last Updated: October 29, 2009   History of Changes

April 7, 2003
October 29, 2009
April 2003
February 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00058240 on ClinicalTrials.gov Archive Site
 
 
 
Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
A Dose-Escalation Study of Flavopiridol (NSC 649890) Administered as a 30 Minute Loading Dose Followed by a 4-Hour Infusion in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

RATIONALE: Drugs used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with previously treated chronic lymphocytic leukemia or lymphocytic lymphoma.

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of flavopiridol in patients with previously treated B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
  • Determine the dose-limiting toxicity and toxicity profile of this drug in these patients.
  • Determine the safety and feasibility of performing dose escalation of this drug in patients who do not experience sever tumor lysis requiring hemodialysis during dose 1.
  • Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients.

Secondary

  • Determine the complete response and overall response rates in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive a loading dose of flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.

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. After the MTD is determined, 12 additional patients are accrued and treated as above at the recommended phase II dose.

After completion of study treatment, patients are followed at 2 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 3-84 patients will be accrued for this study within 28 months.

Phase I
Interventional
Treatment
  • Leukemia
  • Lymphoma
Drug: alvocidib
 
Phelps MA, Lin TS, Johnson AJ, Hurh E, Rozewski DM, Farley KL, Wu D, Blum KA, Fischer B, Mitchell SM, Moran ME, Brooker-McEldowney M, Heerema NA, Jarjoura D, Schaaf LJ, Byrd JC, Grever MR, Dalton JT. Clinical response and pharmacokinetics from a phase 1 study of an active dosing schedule of flavopiridol in relapsed chronic lymphocytic leukemia. Blood. 2009 Mar 19;113(12):2637-45. Epub 2008 Nov 3.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
84
 
February 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, including Waldenstrom's macroglobulinemia, as indicated by the following:

    • Massive or progressive splenomegaly and/or lymphadenopathy
    • Anemia (hemoglobin less than 11 g/dL) or thrombocytopenia (platelet count less than 100,000/mm^3)
    • Weight loss of more than 10% within the past 6 months
    • Grade 2 or 3 fatigue
    • Fevers greater than 100.5º C or night sweats for more than 2 weeks with no evidence of infection
    • Progressive lymphocytosis with an increase of more than 50% over a 2-month period or anticipated doubling time of less than 6 months
  • Received at least 1 prior therapy for CLL

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • WBC less than 200,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times normal (unless due to Gilbert's disease or any of the conditions stated below)*
  • AST no greater than 2 times normal* NOTE: *Unless due to hemolysis, disease infiltration of the liver, or perihepatic lymph node obstruction of biliary flow from the liver

Renal

  • Creatinine no greater than 2.0 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy that would limit survival to less than 2 years
  • No history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) unless inactive for more than 2 years
  • No psychiatric condition that would preclude compliance with treatment or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent chronic corticosteroids
  • No concurrent hormonal therapy except steroids for new adrenal failure or hormonal agents for nondisease-related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other corticosteroid-based antiemetics

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00058240
 
CDR0000287197, OSU-0055, OSU 0055, NCI-5746
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Thomas S. Lin, MD, PhD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP