Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080847
Status:
TERMINATED
Last Update Posted:
2013-01-07
First Post:
2004-04-07
Brief Title:
S0349 Rituximab Cyclophosphamide Doxorubicin Vincristine and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Standard Dose Cyclophosphamide Doxorubicin Vincristine Prednisone CHOP and Rituximab or Rituximab and G3139 Phosphorothioate Oligonucleotide BCL-2 Antisense - NSC-683428 Therapy for Young Patients Age 60 With Advanced Stage Diffuse Large B-Cell NHL of Low and Low-Intermediate IPI Risk
Status:
TERMINATED
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:
This randomized phase II trial is studying rituximab and combination chemotherapy to see how well they work compared to oblimersen rituximab and combination chemotherapy in treating patients with advanced diffuse large B-cell non-Hodgkins lymphoma 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 such as cyclophosphamide doxorubicin vincristine and prednisone work in different ways to stop cancer cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the 1-year progression-free survival probability rate in younger patients with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with 8-cycles of CHOP-rituximab The CHOP-rituximab arm of this study was permanently closed effective 101504 II To estimate the 1-year progression-free survival probability rate in younger patients with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with 8 cycles of CHOP-rituximab-G3139
III To evaluate response complete complete unconfirmed and partial and toxicity for these regimens in this patient population The CHOP-rituximab arm of this study was permanently closed effective 101504 IV To estimate the 1-year progression-free survival and response rate in the subset of patients overexpressing bcl-2 protein
OUTLINE This is a randomized multicenter study Patients are stratified according to age-adjusted International Prognostic Index 0 vs 1 Patients are randomized to 1 of 2 treatment arms Arm I closed to accrual as of 92104
ARM I closed to accrual as of 92104 Patients receive rituximab IV over 6 hours cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5
ARM II Patients receive oblimersen IV continuously on days 1-7 rituximab IV over 6 hours cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 5 and oral prednisone on days 5-10
In both arms treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for up to 5 years
I To estimate the 1-year progression-free survival probability rate in younger patients with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with 8-cycles of CHOP-rituximab The CHOP-rituximab arm of this study was permanently closed effective 101504 II To estimate the 1-year progression-free survival probability rate in younger patients with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with 8 cycles of CHOP-rituximab-G3139
III To evaluate response complete complete unconfirmed and partial and toxicity for these regimens in this patient population The CHOP-rituximab arm of this study was permanently closed effective 101504 IV To estimate the 1-year progression-free survival and response rate in the subset of patients overexpressing bcl-2 protein
OUTLINE This is a randomized multicenter study Patients are stratified according to age-adjusted International Prognostic Index 0 vs 1 Patients are randomized to 1 of 2 treatment arms Arm I closed to accrual as of 92104
ARM I closed to accrual as of 92104 Patients receive rituximab IV over 6 hours cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5
ARM II Patients receive oblimersen IV continuously on days 1-7 rituximab IV over 6 hours cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-20 minutes and vincristine IV over 5-15 minutes on day 5 and oral prednisone on days 5-10
In both arms treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for up to 5 years
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 |
|---|---|---|---|
| CDR0000356049 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0349 | None | None | None |
| U10CA032102 | NIH | None | None |