Lymphoma Clinical Trial
Official title:
Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies
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.
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.
;
Primary Purpose: Treatment
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