Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT00053105
Brief 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.
Study:
NCT00053105
Study Brief:
Protocol Section:
NCT00053105