Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004052
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-12-10
Brief Title:
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
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 may make the body build an immune response to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia
Determine the antileukemic effects of vaccination with these peptides in these patients
OUTLINE Patients receive bcrabl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks on or about days 0 7 21 35 and 56 over 8 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 2 years
Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia
Determine the antileukemic effects of vaccination with these peptides in these patients
OUTLINE Patients receive bcrabl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks on or about days 0 7 21 35 and 56 over 8 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 2 years
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-H99-0036 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067247 | REGISTRY | None | None |