Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003741
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkins Lymphoma
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
HeFi-1 Antibody Therapy in Ki-1 and Hodgkins Lymphomas a Phase I Study
Status:
COMPLETED
Status Verified Date:
2005-03
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 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 with refractory anaplastic large cell lymphoma or Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30 anaplastic large cell lymphoma or Hodgkins lymphoma
Determine the pharmacokinetics of this drug in this patient population
Evaluate the efficacy in terms of correlating immunologic parameters and immunogenicity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response Responding patients may continue treatment at monthly intervals for one year
Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity
Patients are followed monthly
PROJECTED ACCRUAL A total of 9 patients will be accrued for this study
Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30 anaplastic large cell lymphoma or Hodgkins lymphoma
Determine the pharmacokinetics of this drug in this patient population
Evaluate the efficacy in terms of correlating immunologic parameters and immunogenicity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response Responding patients may continue treatment at monthly intervals for one year
Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity
Patients are followed monthly
PROJECTED ACCRUAL A total of 9 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 |
|---|---|---|---|
| CDR0000066859 | REGISTRY | None | None |
| NEDH-97127 | None | None | None |
| NCI-870 | None | None | None |
| NCI-V99-1515 | Registry Identifier | PDQ Physician Data Query | None |