Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062244
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2003-06-05
Brief Title:
Oblimersen in Treating Patients With Relapsed or Refractory Waldenstroms Macroglobulinemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of G3139 Genasense in Patients With Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase III trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstroms macroglobulinemia Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstroms macroglobulinemia
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximally tolerated dose MTD and recommended dosing for Genasense in patients with relapsed or refractory WM following prior chemotherapy Phase I II To determine the response rate to Genasense in patients with relapsed or refractory WM following prior chemotherapy
III To determine the safety of Genasense in patients with relapsed or refractory WM following prior chemotherapy
IV To describe possible clinical benefit from Genasense treatment of relapsed or refractory WM including duration of response survival erythropoietin use improvement in hemoglobin 11 gdl and Improvement in platelet count 100000mm3
OUTLINE This is a multicenter dose-escalation study
Phase I Patients receive oblimersen IV continuously on days 1-7 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 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 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD of oblimersen Patients are followed every 3 months for 2 years
I To determine the maximally tolerated dose MTD and recommended dosing for Genasense in patients with relapsed or refractory WM following prior chemotherapy Phase I II To determine the response rate to Genasense in patients with relapsed or refractory WM following prior chemotherapy
III To determine the safety of Genasense in patients with relapsed or refractory WM following prior chemotherapy
IV To describe possible clinical benefit from Genasense treatment of relapsed or refractory WM including duration of response survival erythropoietin use improvement in hemoglobin 11 gdl and Improvement in platelet count 100000mm3
OUTLINE This is a multicenter dose-escalation study
Phase I Patients receive oblimersen IV continuously on days 1-7 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 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 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MTD of oblimersen Patients are followed every 3 months for 2 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 |
|---|---|---|---|
| N01CM17104 | NIH | None | httpsreporternihgovquickSearchN01CM17104 |
| MC0285 | None | None | None |
| MAYO-MC0285 | None | None | None |
| NCI-5826 | None | None | None |
| CDR0000304634 | None | None | None |