Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059995
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-05-06
Brief Title:
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Open Label Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With RefractoryRelapsed CD30 Lymphoma
Status:
COMPLETED
Status Verified Date:
2009-11
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 MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase III trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma
PURPOSE Phase III trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma
Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients
Determine the pharmacokinetic profile of this drug in these patients
Determine preliminarily the efficacy antilymphoma activity of this drug in these patients
OUTLINE This is an open-label multicenter dose-escalation study
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody 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 an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD
Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma
Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients
Determine the pharmacokinetic profile of this drug in these patients
Determine preliminarily the efficacy antilymphoma activity of this drug in these patients
OUTLINE This is an open-label multicenter dose-escalation study
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody 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 an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD
Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000298995 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-02121 | None | None | None |