Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006380
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2000-10-04
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Evaluation of 131I-J591 Murine Monoclonal Antibody in Patients With Progressive Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 monoclonal antibody therapy in treating patients who have prostate cancer that no longer responds to antiandrogen therapy
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that no longer responds to antiandrogen therapy
Detailed Description:
OBJECTIVES I Determine the biodistribution and normal organ dosimetry of iodine I 131 monoclonal antibody muJ591 in patients with progressive androgen independent prostate cancer II Determine the safety of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Determine the human antimouse antibody response in these patients to this drug V Determine the antitumor effects of this drug in these patients
OUTLINE This is a dose escalation study of iodine I 131 monoclonal antibody muJ591 131I-J591 Patients receive unlabeled monoclonal antibody muJ591 IV over 1 hour followed by 131I-J591 IV over 1 hour Cohorts of 3-6 patients receive escalating doses of 131I-J591 radioactivity is escalated monoclonal antibody dose is fixed 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 Patients are followed at weeks 3 4 6 8 9 and 12 and then every 6 months until month 21
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study over 12 months
OUTLINE This is a dose escalation study of iodine I 131 monoclonal antibody muJ591 131I-J591 Patients receive unlabeled monoclonal antibody muJ591 IV over 1 hour followed by 131I-J591 IV over 1 hour Cohorts of 3-6 patients receive escalating doses of 131I-J591 radioactivity is escalated monoclonal antibody dose is fixed 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 Patients are followed at weeks 3 4 6 8 9 and 12 and then every 6 months until month 21
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study over 12 months
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 |
|---|---|---|---|
| CDR0000068254 | REGISTRY | None | None |
| NCI-G00-1870 | Registry Identifier | PDQ Physician Data Query | None |