Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004184
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2000-01-21
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase III Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine 4B5 Which Mimics the GD2 Antigen in Patients With Melanoma
Status:
COMPLETED
Status Verified Date:
2013-03
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:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have stage III or stage IV melanoma at high risk for recurrence following surgery to remove the tumor
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have stage III or stage IV melanoma at high risk for recurrence following surgery to remove the tumor
Detailed Description:
OBJECTIVES I Determine the toxicity of the human anti-idiotypic monoclonal antibody vaccine 4B5 plus adjuvant sargramostim GM-CSF or alum in patients with stage III or IV melanoma at high risk for recurrence following surgical resection II Determine whether 4B5 is associated with the development of humoral andor cellular anti-anti-idiotypic immune response in these patients III Determine whether the immune response generated against 4B5 is also directed against the melanoma-associated GD2 antigen in these patients IV Determine whether the 4B5 plus adjuvant GM-CSF or alum can elicit an immune response to GD2 in these patients
OUTLINE Patients are assigned sequentially to one of two treatment arms Arm I Patients receive human anti-idiotypic monoclonal antibody vaccine 4B5 in sargramostim GM-CSF subcutaneously SQ on days 0 14 28 and 42 Patients receive GM-CSF alone SQ at vaccination site on days 2 3 and 4 following immunization Arm II Patients receive 4B5 plus alum SQ on days 0 14 28 and 42 Cohorts of 5 patients receive treatment every 2 weeks for up to 4 courses in the absence of unacceptable toxicity
PROJECTED ACCRUAL A maximum of 50 patients 25 per arm will be accrued for this study
OUTLINE Patients are assigned sequentially to one of two treatment arms Arm I Patients receive human anti-idiotypic monoclonal antibody vaccine 4B5 in sargramostim GM-CSF subcutaneously SQ on days 0 14 28 and 42 Patients receive GM-CSF alone SQ at vaccination site on days 2 3 and 4 following immunization Arm II Patients receive 4B5 plus alum SQ on days 0 14 28 and 42 Cohorts of 5 patients receive treatment every 2 weeks for up to 4 courses in the absence of unacceptable toxicity
PROJECTED ACCRUAL A maximum of 50 patients 25 per arm will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1644 | None | None | None |
| UAB-9746 | None | None | None |
| UAB-F980729009 | None | None | None |