Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004858
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-03-07
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkins Lymphoma
Sponsor:
Parker Hughes Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of B43-Genistein Immunoconjugate in Recurrent B-Lineage Acute Lymphoblastic Leukemia and Non Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells and either kill them or deliver cancer-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 recurrent acute lymphoblastic leukemia or non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent acute lymphoblastic leukemia or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of B43-genistein immunoconjugate in patients with recurrent B-cell acute lymphoblastic leukemia or non-Hodgkins lymphoma II Determine the systemic B43-genistein exposure levels in these patients III Determine the antileukemic activity of this regimen in these patients IV Monitor the development of human antimouse antibody in these patients on this regimen
OUTLINE This is a dose escalation study Patients receive B43-genistein immunoconjugate IV over 1 hour on days 1-3 8-10 and 15-17 Treatment continues every 3 weeks in the absence of unacceptable toxicity or until disease progression Cohorts of 3-6 patients receive escalating doses of B43-genistein immunoconjugate 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 Patients are followed every 6 months
PROJECTED ACCRUAL A minimum of 3-15 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive B43-genistein immunoconjugate IV over 1 hour on days 1-3 8-10 and 15-17 Treatment continues every 3 weeks in the absence of unacceptable toxicity or until disease progression Cohorts of 3-6 patients receive escalating doses of B43-genistein immunoconjugate 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 Patients are followed every 6 months
PROJECTED ACCRUAL A minimum of 3-15 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-V00-1583 | None | None | None |
| HUGHES-PHBC-18 | None | None | None |
| HUGHES-IRB-9810018 | None | None | None |