Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513578
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2007-08-06
Brief Title:
Vaccine Therapy and GM-CSF in Treating Patients With Low-Risk or Intermediate-Risk Myelodysplastic Syndrome
Sponsor:
The Vaccine Company
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA 51 VG Adjuvant and Administered With GM-CSF in Low Risk and Intermediate-1 MDS
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Vaccines made from peptides may help the body build an effective immune response to kill cancer cells Colony-stimulating factors such as GM-CSF increase the number of white blood cells and platelets found in bone marrow or peripheral blood Giving vaccine therapy together with GM-CSF may kill more cancer cells
PURPOSE This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome
PURPOSE This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Primary
To determine the immunologic response using a PR1-HLA-A2 tetramer assay to 4 subcutaneous injections of PR1 leukemia peptide vaccine formulated in incomplete Freunds adjuvant IFA followed by sargramostim GM-CSF in patients with low- and intermediate-1-risk myelodysplastic syndromes
Secondary
To determine if non-immunologic responders to 4 subcutaneous injections of PR1 leukemia peptide vaccine formulated in IFA followed by GM-CSF can be converted to immunologic responders by administering 4 additional doses of this treatment
To determine the clinical response to 4 or 8 subcutaneous injections of this vaccine
OUTLINE This is a multicenter study
Patients will receive proteinase PR1 leukemia peptide vaccine TVC-PR1 conjugated with incomplete Freunds adjuvant administered subcutaneously with sargramostim GM-CSF Patients will receive a series of four vaccinations at 3-week intervals Non-immunologic responders after 4 doses of vaccine are eligible to receive 4 additional doses of TVC-PR1 vaccine with the same dose and same dosing intervals Patients who mount an immunologic response after 4 doses will not receive additional doses of TVC-PR1 vaccine
After completion of study therapy patients are followed monthly for up to 6 months
Primary
To determine the immunologic response using a PR1-HLA-A2 tetramer assay to 4 subcutaneous injections of PR1 leukemia peptide vaccine formulated in incomplete Freunds adjuvant IFA followed by sargramostim GM-CSF in patients with low- and intermediate-1-risk myelodysplastic syndromes
Secondary
To determine if non-immunologic responders to 4 subcutaneous injections of PR1 leukemia peptide vaccine formulated in IFA followed by GM-CSF can be converted to immunologic responders by administering 4 additional doses of this treatment
To determine the clinical response to 4 or 8 subcutaneous injections of this vaccine
OUTLINE This is a multicenter study
Patients will receive proteinase PR1 leukemia peptide vaccine TVC-PR1 conjugated with incomplete Freunds adjuvant administered subcutaneously with sargramostim GM-CSF Patients will receive a series of four vaccinations at 3-week intervals Non-immunologic responders after 4 doses of vaccine are eligible to receive 4 additional doses of TVC-PR1 vaccine with the same dose and same dosing intervals Patients who mount an immunologic response after 4 doses will not receive additional doses of TVC-PR1 vaccine
After completion of study therapy patients are followed monthly for up to 6 months
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 |
|---|---|---|---|
| VACCINE-PR1-204 | None | None | None |