Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006669
Status:
WITHDRAWN
Last Update Posted:
2021-10-27
First Post:
2000-12-06
Brief Title:
Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkins Lymphoma
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-cell Non-Hodgkins Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2001-05
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to kill cancer cells Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the response rate in patients with refractory or recurrent CD20 intermediate grade B-cell non-Hodgkins lymphoma treated with rituximab followed by etoposide vincristine doxorubicin cyclophosphamide and prednisone EPOCH II Determine the toxicity of the regimen in these patients
OUTLINE This is a multicenter study Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide vincristine and doxorubicin IV continuously on days 4-7 cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 9 until blood counts recover Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide vincristine and doxorubicin IV continuously on days 4-7 cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 9 until blood counts recover Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1630 | None | None | None |
| WHC-99365 | None | None | None |