Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
Stopped early · Phase 2
Conditions studied: Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
In brief
This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine. Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug. It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer.
Key facts
- Study ID
- NCT00009984
- Run by
- National Cancer Institute (NCI)
- People needed
- 70
- Starts
- 2002-03-01
- Last updated by the study team
- 2013-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of one of the following:
- Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:
- Peripheral blood lymphocytosis greater than 5,000/mm\^3
- Co-expression of the CD5, CD19, CD20, and CD23 surface antigens
- Clonal kappa and lambda light chain expression
- Dim surface immunoglobulin expression
- Small lymphocytic lymphoma
- Relapsed or refractory disease
- Must have received at least 1 prior regimen containing fludarabine
- Meets one of the following criteria:
- Recurrence of lymphocytosis greater than 5,000/mm\^3 or an increase in lymph node volume greater than 50% after achieving complete (CR) or partial response (PR)
- Never achieved a CR or PR after receiving at least 2 courses of fludarabine IV for 5 days at a dose of 25 mg/m\^2/day
- No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g., prolymphocytic leukemia or Richter's syndrome)
- No known CNS disease
- Performance status - Karnofsky 60-100%
- At least 12 weeks
- See Disease Characteristics
- Bilirubin < 2.0 times upper limit of normal (ULN)*
- SGOT < 2.5 times ULN*
- Creatinine < 1.5 times ULN
- No history of cardiac arrhythmia
- No myocardial infarction within the past 6 months
- 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 pre-existing neurotoxicity grade 3 or greater
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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