Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT00024232
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
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?: