Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma.
Drug: fludarabine phosphate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma|
|Study Start Date:||June 2002|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
- Determine the overall response rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma treated with UCN-01 and fludarabine.
- Assess the molecular changes in CLL cells in peripheral blood in patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of UCN-01.
Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 18-46 additional patients receive UCN-01 and fludarabine as above at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for the phase I portion of this study within 6 months. A total of 18-46 patients will be accrued for the phase II portion of this study within 9-23 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045513
|McMaster Children's Hospital at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 465|
|Princess Margaret Hospital at University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Michael R. Crump, MD, FRCPC||Princess Margaret Hospital, Canada|