Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070083
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2003-10-03
Brief Title:
Oblimersen Rituximab Cyclophosphamide Doxorubicin Vincristine and Prednisone in Treating Patients With Stage II Stage III or Stage IV Diffuse Large B-Cell Lymphoma
Sponsor:
British Columbia Cancer Agency
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of G3139 Antisense Oligonucleotide Oblimersen In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2005-06
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 such as cyclophosphamide doxorubicin vincristine and prednisone use different ways to stop cancer cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to the drug Combining oblimersen with rituximab and combination chemotherapy may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of oblimersen when given together with rituximab cyclophosphamide doxorubicin vincristine and prednisone in treating patients with stage II stage III or stage IV large B-cell lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of oblimersen when given together with rituximab cyclophosphamide doxorubicin vincristine and prednisone in treating patients with stage II stage III or stage IV large B-cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and safety of oblimersen administered in combination with rituximab cyclophosphamide doxorubicin vincristine and prednisone in terms of short-term and long-term toxicity in patients with previously untreated stage III or IV or extensive or bulky stage II diffuse large B-cell lymphoma
Determine the maximum tolerated dose of oblimersen administered with this regimen in these patients
Secondary
Determine the remission rate and failure-free progression-free and overall survival of patients treated with this regimen
OUTLINE This is a nonrandomized non-blinded multicenter dose-escalation study of oblimersen
Patients receive CHOP-R therapy comprising cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-10 minutes vincristine IV and rituximab IV over 30-90 minutes on day 1 and oral prednisone on days 1-5 Patients also receive oblimersen IV continuously on days -4 to 3 Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity Patients who discontinue treatment due to unacceptable toxicity to oblimersen may continue to receive standard therapy comprising CHOP-R
NOTE Patients treated at the British Columbia Cancer Agency receive cyclophosphamide doxorubicin vincristine and rituximab on days 1 and 2 and prednisone as above
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined at least 10 patients are treated at that dose level
Patients are followed every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 19-28 patients will be accrued for this study within 5-10 months
Primary
Determine the feasibility and safety of oblimersen administered in combination with rituximab cyclophosphamide doxorubicin vincristine and prednisone in terms of short-term and long-term toxicity in patients with previously untreated stage III or IV or extensive or bulky stage II diffuse large B-cell lymphoma
Determine the maximum tolerated dose of oblimersen administered with this regimen in these patients
Secondary
Determine the remission rate and failure-free progression-free and overall survival of patients treated with this regimen
OUTLINE This is a nonrandomized non-blinded multicenter dose-escalation study of oblimersen
Patients receive CHOP-R therapy comprising cyclophosphamide IV over 15-45 minutes doxorubicin IV over 5-10 minutes vincristine IV and rituximab IV over 30-90 minutes on day 1 and oral prednisone on days 1-5 Patients also receive oblimersen IV continuously on days -4 to 3 Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity Patients who discontinue treatment due to unacceptable toxicity to oblimersen may continue to receive standard therapy comprising CHOP-R
NOTE Patients treated at the British Columbia Cancer Agency receive cyclophosphamide doxorubicin vincristine and rituximab on days 1 and 2 and prednisone as above
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined at least 10 patients are treated at that dose level
Patients are followed every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 19-28 patients will be accrued for this study within 5-10 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCCA-NCI-5818 | None | None | None |
| NCI-5818 | None | None | None |