Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017537
Status:
WITHDRAWN
Last Update Posted:
2013-08-05
First Post:
2001-06-06
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2628-647 and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-11
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 may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic or recurrent cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic or recurrent cancer
Detailed Description:
OBJECTIVES I Determine the optimum biologic dose of MVF-HER-2628-647-CRL 1005 vaccine that will induce anti-HER-2 antibody in patients with metastatic or recurrent cancer II Characterize the nature and severity of toxicity of this drug in these patients III Document any clinical responses to this drug in these patients
OUTLINE This is a dose-escalation study Patients receive MVF-HER-2628-647-CRL 1005 vaccine intramuscularly on days 1 and 29 Cohorts of 5 patients receive escalating doses of MVF-HER-2627-647-CRL 1005 vaccine until at least 2 of 5 patients experience dose-limiting toxicity Patients are followed on days 43 and 57 and every 2 months for at least 1 year
PROJECTED ACCRUAL Approximately 5-25 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive MVF-HER-2628-647-CRL 1005 vaccine intramuscularly on days 1 and 29 Cohorts of 5 patients receive escalating doses of MVF-HER-2627-647-CRL 1005 vaccine until at least 2 of 5 patients experience dose-limiting toxicity Patients are followed on days 43 and 57 and every 2 months for at least 1 year
PROJECTED ACCRUAL Approximately 5-25 patients 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 |
|---|---|---|---|
| UAB-0020 | None | None | None |
| NCI-G01-1955 | None | None | None |