NCT00053105

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Theradex · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	cytarabine
DRUG	methylprednisolone
DRUG	pixantrone dimaleate

Timeline

• Start date: 2002-02-01
• First posted: 2003-01-28
• Last updated: 2009-07-07

Locations

7 sites across 1 country: United States