Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024232
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-09-13
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:
Pilot Trial of Humanized Monoclonal Antibody J591 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 II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer
Determine the biodistribution and dosimetry of this antibody in these patients
Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients
Determine the HAHA response in patients treated with this regimen
Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients
OUTLINE Patients are assigned to one of two treatment groups
Group I Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1
Group II Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I
Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for 4 weeks and then monthly for 3 months
PROJECTED ACCRUAL A total of 14 patients 7 per treatment group will be accrued for this study
Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer
Determine the biodistribution and dosimetry of this antibody in these patients
Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients
Determine the HAHA response in patients treated with this regimen
Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients
OUTLINE Patients are assigned to one of two treatment groups
Group I Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1
Group II Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I
Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for 4 weeks and then monthly for 3 months
PROJECTED ACCRUAL A total of 14 patients 7 per treatment group 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 |
|---|---|---|---|
| NCI-G01-2013 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068903 | REGISTRY | None | None |