Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006009
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2000-07-05
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
Sponsor:
Stanford University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody HuM291 in Patients With CD3 T-cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2003-04
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 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3 T-cell lymphomas
Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population
Determine the response in these patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity Patients achieving a partial response complete response with recurrence or stable disease may receive further therapy
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 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
Patients are followed weekly for 1 month and then monthly for 3 months
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study
Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3 T-cell lymphomas
Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population
Determine the response in these patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity Patients achieving a partial response complete response with recurrence or stable disease may receive further therapy
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 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
Patients are followed weekly for 1 month and then monthly for 3 months
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-102 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068017 | REGISTRY | None | None |