Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089284
Status:
TERMINATED
Last Update Posted:
2019-08-14
First Post:
2004-08-04
Brief Title:
Phase III Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 NHL
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkins Lymphoma NHL Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent Motexafin Gadolinium MGd
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of funding phase II of study was not completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug
This phase III trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II stage III or stage IV relapsed or refractory non-Hodgkins lymphoma
This phase III trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II stage III or stage IV relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
This is a phase I dose-escalation study of motexafin gadolinium followed by a phase II study Patients are stratified according to extent of lymphomatous involvement 5 vs 5 but 24 of cellular elements
Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity DLT OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT
Once the MTD is determined additional patients are treated at that dose level as in phase I
Patients are followed weekly for 3 months and then monthly for 5 years
Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity DLT OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT
Once the MTD is determined additional patients are treated at that dose level as in phase I
Patients are followed weekly for 3 months and then monthly for 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 |
|---|---|---|---|
| 1346001 | OTHER | Northwestern University IRB | None |