Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081172
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2004-04-07
Brief Title:
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma Cancer of the Prostate
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS Lu-J591 In Patients With Metastatic Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2006-04
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 Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells
PURPOSE This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma cancer of the prostate
PURPOSE This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma cancer of the prostate
Detailed Description:
OBJECTIVES
Primary
Determine the prostate-specific antigen PSA response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591
Determine the measurable disease response rate in patients treated with this drug
Secondary
Determine the toxicity of this drug in these patients
Determine the duration of biochemical PSA andor measurable disease response in patients treated with this drug
Determine the incidence of human anti-J591 antibody HAHA response in patients treated with this drug
Correlate hematological toxicity of this drug with bone marrow involvement bone scan index in these patients
Determine the survival rate in patients treated with this drug
Determine the targeting of this drug to known tumor sites in these patients
Determine the tumor-absorbed radiation dose in patients treated with this drug
OUTLINE This is a multicenter open-label study
Patients receive a single dose of lutetium Lu 177 monoclonal antibody J591 IV on day 1 Patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 17-32 patients will be accrued for this study
Primary
Determine the prostate-specific antigen PSA response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591
Determine the measurable disease response rate in patients treated with this drug
Secondary
Determine the toxicity of this drug in these patients
Determine the duration of biochemical PSA andor measurable disease response in patients treated with this drug
Determine the incidence of human anti-J591 antibody HAHA response in patients treated with this drug
Correlate hematological toxicity of this drug with bone marrow involvement bone scan index in these patients
Determine the survival rate in patients treated with this drug
Determine the targeting of this drug to known tumor sites in these patients
Determine the tumor-absorbed radiation dose in patients treated with this drug
OUTLINE This is a multicenter open-label study
Patients receive a single dose of lutetium Lu 177 monoclonal antibody J591 IV on day 1 Patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 17-32 patients 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 |
|---|---|---|---|
| CDR0000360629 | REGISTRY | PDQ Physician Data Query | None |