Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003391
Status:
COMPLETED
Last Update Posted:
2009-10-12
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase I Trial of Monoclonal Antibody muJ591 in Patients With Hormone-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2009-10
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 muJ591 monoclonal antibody in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase I trial to study the effectiveness of muJ591 monoclonal antibody in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Define the toxicity and maximum tolerated dose of monoclonal antibody muJ591 in patients with hormone independent prostate cancer II Define the pharmacokinetics and biodistribution of monoclonal antibody muJ591 in these patients III Define the human antimouse antibody response to this therapy IV Define the preliminary efficacy of this therapy in these patients
OUTLINE This is a dose escalation study Patients receive a single dose of intravenous iodine I 131-labeled monoclonal antibody muJ591 on day 0 combined with an unlabeled cold dose of monoclonal antibody muJ591 Anterior and posterior imaging is obtained 1 hour after labeled muJ591 administration and on days 0 2 4 and 6 Subsequent cohorts of 3-6 patients receive fixed iodine-labeled doses with escalating cold doses of monoclonal antibody muJ591 until the maximum tolerated dose is reached Patients are followed for a minimum of 8 weeks after muJ591 therapy or until disease progression Patients with stable or responding disease who are human anti-mouse antibody negative may receive subsequent treatments at the discretion of the principal investigator
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive a single dose of intravenous iodine I 131-labeled monoclonal antibody muJ591 on day 0 combined with an unlabeled cold dose of monoclonal antibody muJ591 Anterior and posterior imaging is obtained 1 hour after labeled muJ591 administration and on days 0 2 4 and 6 Subsequent cohorts of 3-6 patients receive fixed iodine-labeled doses with escalating cold doses of monoclonal antibody muJ591 until the maximum tolerated dose is reached Patients are followed for a minimum of 8 weeks after muJ591 therapy or until disease progression Patients with stable or responding disease who are human anti-mouse antibody negative may receive subsequent treatments at the discretion of the principal investigator
PROJECTED ACCRUAL A total of 30 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-V98-1426 | None | None | None |
| NYH-CMC-0498-213 | None | None | None |