Chronic Lymphocytic Leukemia Clinical Trial
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell leukemia-cll/" >chronic lymphocytic leukemia.
Full Description
OBJECTIVES:
Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia.
Determine the overall response rate (complete and partial) in patients treated with this regimen.
Determine the duration of response in patients treated with this regimen.
OUTLINE: This is an open-label, phase I, dose-escalation study of thalidomide followed by a phase II study.
Phase I: Beginning on day 1, patients receive oral thalidomide once daily for up to 6 months. Beginning on day 7, patients also receive fludarabine IV over 30 minutes daily for 5 days. Treatment with fludarabine repeats every 28-35 days for up to 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of thalidomide 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.
Phase II: Patients receive fludarabine and thalidomide as in phase I at the MTD.
Patients are followed at 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years.
PROJECTED ACCRUAL: Up to 45 patients (≥ 9 for the phase I portion and ≤ 36 for the phase II portion) will be accrued for this study within 8 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) based on the following criteria:
Peripheral blood lymphocytosis > 5,000/mm^3
Co-expression of CD5, CD19 or CD20, and CD23 surface antigens
Clonal kappa or lambda light chain expression
No recurrent or refractory CLL
No other lymphoproliferative diseases or diseases due to transformation of CLL, such as prolymphocytic leukemia or Richter's syndrome
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 60-100%
Life expectancy
At least 12 weeks
Hematopoietic
See Disease Characteristics
Hepatic
Bilirubin < 1.5 mg/dL
AST < 2.5 times upper limit of normal
Renal
Creatinine ≤ 1.5 mg/dL
Cardiovascular
No cardiac arrhythmia within the past 6 months
No myocardial infarction within the past 6 months
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use at least 1 highly active and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study treatment
Patients must have sufficient mental capacity to understand the study explanation and provide informed consent
No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
No active serious infection uncontrolled by antibiotics
No medical condition or reason that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Other
No prior therapy for CLL
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There is 1 Location for this study
Buffalo New York, 14263, United States
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