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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma  Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
For Condition: refractory chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia,Waldenstrom's Macroglobulinemia,recurrent diffuse small lymphocytic/marginal zone lymphoma
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as flavopiridol use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who have previously treated chronic lymphocytic leukemia or lymphocyticlymphoma.
Details: OBJECTIVES: - 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 pharmacokinetics and cellular pharmacodynamics of this drug in these patients. - 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 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. After the MTD is determined, twelve additional patients are accrued and treated as above at the recommended phase II dose. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 - Platelet count at least 50,000/mm^3* NOTE: *Cytopenias allowed 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 or disease infiltration of 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasLin, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Thomas Lin 614-293-9316
Additional Information:
Study ID Numbers: CDR0000287197; OSU-02H0282,NCI-5746,OSU-0055
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058240
Other B-Cell Chronic Lymphocytic Leukemia Studies:
1. Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
2. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
3. Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
4. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
5. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
Related Studies:
Other B-cell Chronic Lymphocytic Leukemia Clinical Trials
Other Ohio Clinical Trials
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Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
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