Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053105
Status:
UNKNOWN
Last Update Posted:
2009-07-07
First Post:
2003-01-27
Brief Title:
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkins Lymphoma
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-Hodgkins lymphoma
PURPOSE Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkins 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-Hodgkins 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
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-Hodgkins 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CWRU-050213J | None | None | None |
| THERADEX-AZA-I-05 | None | None | None |
| NOVUSPHARMA-AZA-I-05 | None | None | None |
| NOVUSPHARMA-AZA-1401 | None | None | None |