Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003784
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
S9911 Combination Chemotherapy Plus Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkins Lymphomas
Status:
COMPLETED
Status Verified Date:
2013-01
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 Combining more than one drug may kill more cancer cells Monoclonal antibodies 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 followed by monoclonal antibody therapy in treating patients who have newly diagnosed follicular non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by monoclonal antibody therapy in treating patients who have newly diagnosed follicular non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the 2 year failure free survival rate of patients with newly diagnosed follicular lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP followed by iodine I 131 monoclonal antibody anti-B1 II Determine the complete and partial response rates of these patients after this therapy III Evaluate the toxicity of this regimen in these patients IV Determine the rate of disappearance of cells with clonal t1418bcl2 rearrangements from the peripheral blood and bone marrow after this therapy in these patients
OUTLINE Patients receive cyclophosphamide IV over 15 minutes doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment is repeated every 21 days for up to 6 courses Within 4-8 weeks after the last course of chemotherapy patients who achieve at least a partial response and have less than 25 bone marrow involvement begin immunotherapy Patients receive unlabeled monoclonal antibody anti-B1 MOAB anti-B1 IV over 1 hour then iodine I 131 MOAB anti-B1 IV over 20 minutes on day 1 This regimen is repeated on day 8 Patients are followed every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 1 year
OUTLINE Patients receive cyclophosphamide IV over 15 minutes doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment is repeated every 21 days for up to 6 courses Within 4-8 weeks after the last course of chemotherapy patients who achieve at least a partial response and have less than 25 bone marrow involvement begin immunotherapy Patients receive unlabeled monoclonal antibody anti-B1 MOAB anti-B1 IV over 1 hour then iodine I 131 MOAB anti-B1 IV over 20 minutes on day 1 This regimen is repeated on day 8 Patients are followed every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| S9911 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |