Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040586
Status:
COMPLETED
Last Update Posted:
2007-01-22
First Post:
2002-07-01
Brief Title:
Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Subcutaneous Interleukin-2
Sponsor:
BZL Biologics
Organization:
BZL Biologics
Study Overview
Official Title:
Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2002-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer in combination with recombinant interleukin-2 Proleukin Aldesleukin The study is an open-label non-randomized phase II study for patients with documented hormone refractory prostate cancer
Detailed Description:
In this Phase II open label study patients will receive daily low-dose subcutaneous rIL-2 12 x 106 IUm2day continuously beginning on day 1 Patients will receive 3 weeks of IL-2 and on day 22 will receive the monoclonal antibody huJ591 via IV 25mgm2 for 3 consecutive weeks Il-2 will be continued for 2 additional weeks for a total of 8 weeks The 8 week regimen will constitute 1 cycle of therapy Patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy
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