Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058435
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2003-04-07
Brief Title:
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial Fallopian Tube or Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian Fallopian Tube or Peritoneal 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 Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells
PURPOSE Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial fallopian tube or peritoneal cancer
PURPOSE Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial fallopian tube or peritoneal cancer
Determine an optimal dose and route of this vaccine for a phase II study
Determine the immune response induced by this vaccination in these patients
Determine the time to development of objective tumor response in patients treated with this regimen
OUTLINE This is a multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine MOAB ACA125 intramuscularly IM on weeks 0 2 4 6 10 and 14 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive higher-dose MOAB ACA125 IM as in arm I
Arm III Patients receive lower-dose MOAB ACA125 subcutaneously SC on weeks 0 2 4 6 10 and 14 in the absence of disease progression or unacceptable toxicity
Arm IV Patients receive higher-dose MOAB ACA125 SC as in arm III Patients are followed every 6-12 weeks for 2 years
PROJECTED ACCRUAL A total of 40 patients 10 patients per cohort will be accrued for this study
Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial fallopian tube or peritoneal cancer
Determine an optimal dose and route of this vaccine for a phase II study
Determine the immune response induced by this vaccination in these patients
Determine the time to development of objective tumor response in patients treated with this regimen
OUTLINE This is a multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine MOAB ACA125 intramuscularly IM on weeks 0 2 4 6 10 and 14 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive higher-dose MOAB ACA125 IM as in arm I
Arm III Patients receive lower-dose MOAB ACA125 subcutaneously SC on weeks 0 2 4 6 10 and 14 in the absence of disease progression or unacceptable toxicity
Arm IV Patients receive higher-dose MOAB ACA125 SC as in arm III Patients are followed every 6-12 weeks for 2 years
PROJECTED ACCRUAL A total of 40 patients 10 patients per cohort 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 |
|---|---|---|---|
| CELLCONTROL-MSKCC-02122 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000288831 | REGISTRY | None | None |