Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004039
Status:
WITHDRAWN
Last Update Posted:
2015-08-19
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patient accruals
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 interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma
PURPOSE Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma
Detailed Description:
OBJECTIVES I Determine the toxicity of cyclophosphamide doxorubicin vincristine and prednisone CHOP with either interferon alfa or rituximab in patients with stage III or IV high risk indolent or intermediate B-cell lymphoma II Determine the objective tumor response rate and duration of response for these regimens in these patients III Determine the failure free survival and overall survival for these patients on these regimens IV Compare the response rate and survival rate of these patients on these regimens to similar patients treated in published studies V Compare the toxicities of these regimens in these patients VI Determine the quality of life of these patients on these regimens
OUTLINE This is a multicenter study Patients are assigned to one of two treatment arms Arm I Patients receive rituximab IV on day 0 and cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 followed by oral prednisone on days 1-5 Arm II Patients receive interferon alfa subcutaneously on days 22-26 and cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 followed by oral prednisone on days 1-5 Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and prior to chemotherapy for each course Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually for up to 10 years
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per treatment arm will be accrued for this study
OUTLINE This is a multicenter study Patients are assigned to one of two treatment arms Arm I Patients receive rituximab IV on day 0 and cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 followed by oral prednisone on days 1-5 Arm II Patients receive interferon alfa subcutaneously on days 22-26 and cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 followed by oral prednisone on days 1-5 Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and prior to chemotherapy for each course Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually for up to 10 years
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per treatment arm 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-V98-1494 | None | None | None |
| CBRG-9807 | None | None | None |