Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069966
Status:
UNKNOWN
Last Update Posted:
2009-07-07
First Post:
2003-10-03
Brief Title:
Pixantrone Cytarabine Methylprednisolone and Cisplatin in Treating Patients With Aggressive Non-Hodgkins Lymphoma in First Relapse
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of BBR 2778 in Combination With Cytarabine Methylprednisolone and Cisplatin BSHAP as Salvage in Patients With Relapsed Aggressive Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2004-11
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 such as pixantrone cytarabine methylprednisolone and cisplatin work in 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 II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the antitumor activity of pixantrone cytarabine methylprednisolone and cisplatin in patients with aggressive non-Hodgkins lymphoma in first relapse
Determine the safety and tolerability of this regimen in these patients
Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients
OUTLINE This is an open-label multicenter study
Salvage therapy Patients receive pixantrone IV over 1 hour on day 1 cisplatin IV over 30 minutes on days 1-4 methylprednisolone IV over 15-30 minutes on days 1-5 and cytarabine IV over 2 hours on day 5 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
After 2 courses of salvage therapy patients are re-evaluated and treated as follows
Complete response CR or partial response PR Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation ASCT proceed to mobilization therapy high-dose chemotherapy and ASCT Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity
Stable disease Patients with stable disease continue to receive salvage therapy for up to 6 courses Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy high-dose chemotherapy and ASCT off study at the investigators discretion
Mobilization therapy optional regimen regimen used for mobilization is at the investigators discretion Patients receive rituximab IV on days 1 and 7 pixantrone IV over 1 hour on day 2 cisplatin IV over 30 minutes on days 2-5 cytarabine IV over 2 hours on day 6 and methylprednisolone IV over 15-30 minutes on days 2-6 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 7 and continuing until blood counts recover Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells
NOTE If this mobilization regimen is used patients with T-cell lymphoma do not receive rituximab
High-dose chemotherapy and ASCT Patients receive high-dose chemotherapy and ASCT per institutional standard practice
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Determine the antitumor activity of pixantrone cytarabine methylprednisolone and cisplatin in patients with aggressive non-Hodgkins lymphoma in first relapse
Determine the safety and tolerability of this regimen in these patients
Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients
OUTLINE This is an open-label multicenter study
Salvage therapy Patients receive pixantrone IV over 1 hour on day 1 cisplatin IV over 30 minutes on days 1-4 methylprednisolone IV over 15-30 minutes on days 1-5 and cytarabine IV over 2 hours on day 5 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
After 2 courses of salvage therapy patients are re-evaluated and treated as follows
Complete response CR or partial response PR Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation ASCT proceed to mobilization therapy high-dose chemotherapy and ASCT Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity
Stable disease Patients with stable disease continue to receive salvage therapy for up to 6 courses Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy high-dose chemotherapy and ASCT off study at the investigators discretion
Mobilization therapy optional regimen regimen used for mobilization is at the investigators discretion Patients receive rituximab IV on days 1 and 7 pixantrone IV over 1 hour on day 2 cisplatin IV over 30 minutes on days 2-5 cytarabine IV over 2 hours on day 6 and methylprednisolone IV over 15-30 minutes on days 2-6 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 7 and continuing until blood counts recover Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells
NOTE If this mobilization regimen is used patients with T-cell lymphoma do not receive rituximab
High-dose chemotherapy and ASCT Patients receive high-dose chemotherapy and ASCT per institutional standard practice
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 75 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 |
|---|---|---|---|
| NOVUSPHARMA-AZA-II-02 | None | None | None |
| THERADEX-AZA-II-02 | None | None | None |
| CWRU-NOVU-1403 | None | None | None |
| SUNY-HSC-4849 | None | None | None |