Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086944
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2004-07-08
Brief Title:
Oblimersen Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of G3139 Genasense in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkins Lymphoma
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:
This phase III trial is studying the side effects and best dose of oblimersen when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with relapsed or refractory aggressive 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 ifosfamide carboplatin and etoposide work in different ways to stop cancer cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of oblimersen when given in combination with rituximab ifosfamide carboplatin and etoposide in patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma
II Determine the safety and toxicity of this regimen in these patients III Determine the complete and partial response rate in patients treated with this regimen
SECONDARY OBJECTIVES
I Determine the duration of response overall survival and time to progression in patients treated with this regimen
II Determine the effect of this regimen on hematopoietic stem cell kinetics and yield from these patients
OUTLINE This is a multicenter phase I dose-escalation study of oblimersen followed by a phase II study
Phase I Patients receive GRICE comprising oblimersen IV continuously on days 1-5 rituximab IV ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4 and etoposide IV over 30 minutes once daily on days 4-6 Treatment repeats every 14 days for 3 courses Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 7 and continuing until blood counts recover OR one dose of pegfilgrastim SC on day 7 of courses 1 and 2 For course 3 all patients receive G-CSF SC twice daily beginning on day 7 and continuing until stem cell collection is complete Patients with responding disease who are not eligible for autologous SCT may receive up to 8 total courses of GRICE or 2 additional courses beyond maximal response Patients with responding disease to GRICE who are eligible for autologous SCT are removed from the study and undergo autologous SCT off study 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
Phase II Patients receive oblimersen at the MTD determined in phase I and rituximab ifosfamide carboplatin and etoposide followed by G-CSF or pegfilgrastim as in phase I In both phases treatment continues in the absence of disease progression unacceptable toxicity or the patient becomes a candidate for autologous SCT Patients are followed for survival
I Determine the maximum tolerated dose of oblimersen when given in combination with rituximab ifosfamide carboplatin and etoposide in patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma
II Determine the safety and toxicity of this regimen in these patients III Determine the complete and partial response rate in patients treated with this regimen
SECONDARY OBJECTIVES
I Determine the duration of response overall survival and time to progression in patients treated with this regimen
II Determine the effect of this regimen on hematopoietic stem cell kinetics and yield from these patients
OUTLINE This is a multicenter phase I dose-escalation study of oblimersen followed by a phase II study
Phase I Patients receive GRICE comprising oblimersen IV continuously on days 1-5 rituximab IV ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4 and etoposide IV over 30 minutes once daily on days 4-6 Treatment repeats every 14 days for 3 courses Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 7 and continuing until blood counts recover OR one dose of pegfilgrastim SC on day 7 of courses 1 and 2 For course 3 all patients receive G-CSF SC twice daily beginning on day 7 and continuing until stem cell collection is complete Patients with responding disease who are not eligible for autologous SCT may receive up to 8 total courses of GRICE or 2 additional courses beyond maximal response Patients with responding disease to GRICE who are eligible for autologous SCT are removed from the study and undergo autologous SCT off study 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
Phase II Patients receive oblimersen at the MTD determined in phase I and rituximab ifosfamide carboplatin and etoposide followed by G-CSF or pegfilgrastim as in phase I In both phases treatment continues in the absence of disease progression unacceptable toxicity or the patient becomes a candidate for autologous SCT Patients are followed for survival
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 |
|---|---|---|---|
| CDR0000371904 | REGISTRY | PDQ Physician data Query | httpsreporternihgovquickSearchN01CM62201 |
| 12975A | None | None | None |
| N01CM62201 | NIH | None | None |