Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007865
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase II Trial of Ifosfamide Carboplatin and Etoposide ICE Chemotherapy in Combination With Rituximab as Salvage Therapy
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkins lymphoma treated with ifosfamide carboplatin and etoposide ICE in combination with rituximab
Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients
OUTLINE Patients receive rituximab IV on days 1 8 and 15 and ifosfamide IV over 1 hour etoposide IV over 2 hours and carboplatin IV on days 2-4 Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 19-39 patients will be accrued for this study within 2 years
Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkins lymphoma treated with ifosfamide carboplatin and etoposide ICE in combination with rituximab
Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients
OUTLINE Patients receive rituximab IV on days 1 8 and 15 and ifosfamide IV over 1 hour etoposide IV over 2 hours and carboplatin IV on days 2-4 Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 19-39 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1635 | REGISTRY | National Cancer Institute | httpsreporternihgovquickSearchP30CA036727 |
| P30CA036727 | NIH | None | None |