Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055783
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2003-03-06
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkins Lymphoma
Sponsor:
Stanford University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Hu1D10 in Recurrent Hodgkins Disease
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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate of patients with recurrent Hodgkins lymphoma treated with monoclonal antibody Hu1D10
Determine the duration of response and progression-free survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive monoclonal antibody Hu1D10 IV over 2 hours Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity
Patients are followed at weeks 5 and 8 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study within approximately 12 months
Determine the response rate of patients with recurrent Hodgkins lymphoma treated with monoclonal antibody Hu1D10
Determine the duration of response and progression-free survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive monoclonal antibody Hu1D10 IV over 2 hours Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity
Patients are followed at weeks 5 and 8 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study within approximately 12 months
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 |
|---|---|---|---|
| CDR0000271198 | REGISTRY | PDQ Physician Data Query | None |