Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003959
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination of Patients With Myelodysplastic Syndrome Against Mutated RAS Proteins A Pilot Trial
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:
RATIONALE A vaccine made from a persons myelodysplasia cells may make the body build an immune response to kill cancer cells Combining vaccine therapy with sargramostim may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have myelodysplastic syndrome
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine whether a specific T-cell response can be induced in patients with myelodysplastic syndrome treated with mutant N- K- or H-ras peptide vaccine limited to the specific N- K- or H-ras peptide mutation in their bone marrow and intradermal sargramostim GM-CSF II Determine whether HLA type or the ability to respond immunologically to common recall antigens correlates with the induction of anti-ras immune responses in these patients treated with this regimen III Assess toxicity of mutant N- K- or H-ras peptide vaccine in these patients
OUTLINE Patients receive sargramostim GM-CSF intradermally on days 1-10 Patients receive mutant N- K- or H-ras peptide vaccine limited to the specific N- K- or H-ras mutation in their bone marrow intradermally on day 7 Treatment repeats every 4 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 2 and 6 weeks after the last vaccination
PROJECTED ACCRUAL A total of 25-70 patients will be accrued for this study over 12-15 months
OUTLINE Patients receive sargramostim GM-CSF intradermally on days 1-10 Patients receive mutant N- K- or H-ras peptide vaccine limited to the specific N- K- or H-ras mutation in their bone marrow intradermally on day 7 Treatment repeats every 4 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 2 and 6 weeks after the last vaccination
PROJECTED ACCRUAL A total of 25-70 patients will be accrued for this study over 12-15 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 |
|---|---|---|---|
| NCI-G99-1542 | None | None | None |
| MSKCC-98037 | None | None | None |