RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.
OBJECTIVES: * Determine the maximum tolerated dose of cladribine when administered after bryostatin 1 in patients with relapsed chronic lymphocytic leukemia. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of cladribine. Patients receive bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Cohorts of 3-6 patients receive escalating dose levels of cladribine 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 at 3 weeks. PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
80
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.