Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004101
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-12-10
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Humanized 1D10 Monoclonal Antibody Hu1D10 In Patients With Relapsed Non-Hodgkins Lymphoma NHL
Status:
COMPLETED
Status Verified Date:
2001-05
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:
Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkins lymphoma Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
Detailed Description:
OBJECTIVES
I Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkins lymphoma expressing the antigen recognized by Hu1D10
II Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients
III Evaluate the pharmacokinetics compare the pharmacology at different dose levels and determine the optimal biological dose of this drug in these patients
IV Evaluate any antilymphoma effects of this drug in these patients
OUTLINE This is a dose escalation multicenter study
Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1 8 15 and 22 Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity Once the MTD is determined an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5
Patients are followed at 4 weeks 50 days and periodically thereafter until disease progression
I Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkins lymphoma expressing the antigen recognized by Hu1D10
II Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients
III Evaluate the pharmacokinetics compare the pharmacology at different dose levels and determine the optimal biological dose of this drug in these patients
IV Evaluate any antilymphoma effects of this drug in these patients
OUTLINE This is a dose escalation multicenter study
Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1 8 15 and 22 Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity Once the MTD is determined an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5
Patients are followed at 4 weeks 50 days and periodically thereafter until disease progression
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-T99-0019 | None | None | None |
| UIHC-UICC-LW-02 | None | None | None |