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
- 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
- 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
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.
Primary Purpose: Treatment
Luis Fayad, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Marlene and Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201-1595|
|Arizona Clinical Research Center||Tucson, Arizona 85712|
|Highlands Oncology Group||Springdale, Arkansas 72764|
|Boston Baskin Cancer Group, University Tennessee||Memphis, Tennessee 38104|