Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004918
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2000-03-07
Brief Title:
Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of PR1 NSC 698102 Human Leukemia Peptide Vaccine With Montanide ISA 51 NSC 675756 or Montanide ISA 51 VG NSC 737063 Adjuvant
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia acute myeloid leukemia or myelodysplastic syndrome This phase III trial is studying the side effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well they work in treating patients with chronic myeloid leukemia acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate both toxicity and immune response efficacy of PR1 peptide PR1 leukemia peptide vaccine administered subcutaneously
SECONDARY OBJECTIVES
I To evaluate possible clinical efficacy of PR1 peptide vaccine preparation with Montanide ISA 51 or Montanide ISA 51 VG adjuvant in high-risk HLA-A2 positive patients with myeloid leukemias
OUTLINE This is a phase I dose-escalation study of PR1 leukemia peptide vaccine followed by a phase II randomized study
Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51 ISA-51 subcutaneously SC once every 3 weeks for 18 weeks for a total of 6 vaccinations Patients also receive sargramostim GM-CSF SC with each vaccination
Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Additional patients are accrued to the phase II portion of the study and are randomized to receive one of three dose levels of PR1 leukemia peptide vaccine with ISA-51 Patients in each of the 3 arms receive treatment as in the phase I portion of the study
Patients achieving a clinical response andor clinical response to the vaccine whose disease progresses within 6-12 months after the first set of vaccinations may receive additional vaccine as before
Patients achieving a clinical response or immune reaction to the vaccine are followed at least monthly until death or until the clinical response andor immune reaction is lost
PROJECTED ACCRUAL A total of 3-9 patients will be accrued for the phase I dose escalation portion of this study A maximum of 60 patients 20 per arm will be accrued for the phase II randomized portion of this study
I To evaluate both toxicity and immune response efficacy of PR1 peptide PR1 leukemia peptide vaccine administered subcutaneously
SECONDARY OBJECTIVES
I To evaluate possible clinical efficacy of PR1 peptide vaccine preparation with Montanide ISA 51 or Montanide ISA 51 VG adjuvant in high-risk HLA-A2 positive patients with myeloid leukemias
OUTLINE This is a phase I dose-escalation study of PR1 leukemia peptide vaccine followed by a phase II randomized study
Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51 ISA-51 subcutaneously SC once every 3 weeks for 18 weeks for a total of 6 vaccinations Patients also receive sargramostim GM-CSF SC with each vaccination
Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Additional patients are accrued to the phase II portion of the study and are randomized to receive one of three dose levels of PR1 leukemia peptide vaccine with ISA-51 Patients in each of the 3 arms receive treatment as in the phase I portion of the study
Patients achieving a clinical response andor clinical response to the vaccine whose disease progresses within 6-12 months after the first set of vaccinations may receive additional vaccine as before
Patients achieving a clinical response or immune reaction to the vaccine are followed at least monthly until death or until the clinical response andor immune reaction is lost
PROJECTED ACCRUAL A total of 3-9 patients will be accrued for the phase I dose escalation portion of this study A maximum of 60 patients 20 per arm will be accrued for the phase II randomized portion of 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 |
|---|---|---|---|
| DM 97-325 | None | None | None |