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Brief Title: UCN-01 and Fludarabine in Treating Patients With Recurrent or Refractory Lymphoma or Leukemia
Official Title: Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies
Study ID: NCT00019838
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given with UCN-01 in treating patients with recurrent or refractory low-grade lymphoma or leukemia.
Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose and toxic effects of fludarabine when administered with UCN-01 in patients with recurrent or refractory low-grade or indolent lymphoid malignancies. * Determine, preliminarily, the activity of this treatment regimen in these patients. * Assess the pharmacokinetics of this treatment regimen in these patients. OUTLINE: This is a dose-escalation study of fludarabine. Patients receive UCN-01 IV over 72 hours on days 1-3 alone during course 1 and over 36 hours on days 1-2 during courses 2-7. Patients also receive fludarabine IV over 30 minutes beginning on day 1 and continuing for up to 5 days during courses 2-7. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 6 months, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
NCI - Center for Cancer Research, Bethesda, Maryland, United States
Name: Wyndham H. Wilson, MD, PhD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR