Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398138
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2006-11-09
Brief Title:
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia Myelodysplastic Syndromes Non-Small Cell Lung Cancer or Mesothelioma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms
Status:
COMPLETED
Status Verified Date:
2016-02
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 made from peptides may help the body build an effective immune response to kill cancer cells Biological therapies such as GM-CSF may stimulate the immune system in different ways and stop cancer cells from growing Giving vaccine therapy together with GM-CSF may kill more cancer cells
PURPOSE This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia myelodysplastic syndromes non-small cell lung cancer or mesothelioma
PURPOSE This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia myelodysplastic syndromes non-small cell lung cancer or mesothelioma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and immunogenicity of the Wilms tumor-1 analog peptide vaccine in patients with acute myeloid leukemia myelodysplastic syndromes non-small cell lung cancer or mesothelioma
Secondary
Determine the antitumor effects of this vaccine in these patients
OUTLINE This is a pilot study Patients are stratified according to disease type acute myeloid leukemia AML or myelodysplastic syndromes MDS vs non-small cell lung cancer or mesothelioma
Patients receive vaccine comprising Wilms-tumor 1 WT-1 analog peptide emulsified in Montanide ISA-51 subcutaneously SC once in weeks 0 4 6 8 10 and 12 and sargramostim GM-CSF SC twice in weeks 0 4 6 8 10 and 12 on the day of and 2 days prior to each vaccination Patients who have an immunologic response and have no disease progression may receive up to 6 more vaccinations approximately 1 month apart
Blood samples are collected at baseline week 8 and week 14 Samples are examined by polymerase chain reaction PCR to measure levels of WT-1 and by T-cell proliferative response delayed-type hypersensitivity against WT-1 peptides or ELISPOT to measure immune response
Bone marrow samples are collected from patients with AML or MDS at baseline and week 14 Samples are examined by PCR to measure levels of WT-1 and by multiparameter flow cytometry to measure residual disease
Primary
Determine the safety and immunogenicity of the Wilms tumor-1 analog peptide vaccine in patients with acute myeloid leukemia myelodysplastic syndromes non-small cell lung cancer or mesothelioma
Secondary
Determine the antitumor effects of this vaccine in these patients
OUTLINE This is a pilot study Patients are stratified according to disease type acute myeloid leukemia AML or myelodysplastic syndromes MDS vs non-small cell lung cancer or mesothelioma
Patients receive vaccine comprising Wilms-tumor 1 WT-1 analog peptide emulsified in Montanide ISA-51 subcutaneously SC once in weeks 0 4 6 8 10 and 12 and sargramostim GM-CSF SC twice in weeks 0 4 6 8 10 and 12 on the day of and 2 days prior to each vaccination Patients who have an immunologic response and have no disease progression may receive up to 6 more vaccinations approximately 1 month apart
Blood samples are collected at baseline week 8 and week 14 Samples are examined by polymerase chain reaction PCR to measure levels of WT-1 and by T-cell proliferative response delayed-type hypersensitivity against WT-1 peptides or ELISPOT to measure immune response
Bone marrow samples are collected from patients with AML or MDS at baseline and week 14 Samples are examined by PCR to measure levels of WT-1 and by multiparameter flow cytometry to measure residual disease
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 |
|---|---|---|---|
| MSKCC-06085 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA023766 |
| P30CA008748 | NIH | None | None |
| P01CA023766 | NIH | None | None |