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A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's 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 trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
OBJECTIVES: * Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. * Determine the dose-limiting toxic effects of this regimen in these patients. * Determine the relationship between toxicity and systemic exposure to this regimen in these patients. * Determine the safety of this regimen in these patients. * Assess the pharmacokinetics of this regimen in these patients. * Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone. Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Arizona Clinical Research Center
Tucson, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Boston Baskin Cancer Group, University Tennessee
Memphis, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Start Date
February 1, 2002
Last Updated
July 7, 2009
cisplatin
DRUG
cytarabine
DRUG
methylprednisolone
DRUG
pixantrone dimaleate
DRUG
Lead Sponsor
Theradex
NCT06337318
NCT07388563
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