Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005630
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras A Pilot Trial
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 tumor cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood
PURPOSE Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine limited to the specific K-ras peptide mutation in their tumors and sargramostim GM-CSF
Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive sargramostim GM-CSF intradermally ID on days 1-10 beginning a maximum of 6 months after complete surgical resection Patients receive mutant K-ras peptide vaccine limited to the specific K-ras mutation in their tumors ID on day 7 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 and 12 weeks
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 18 months
Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine limited to the specific K-ras peptide mutation in their tumors and sargramostim GM-CSF
Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive sargramostim GM-CSF intradermally ID on days 1-10 beginning a maximum of 6 months after complete surgical resection Patients receive mutant K-ras peptide vaccine limited to the specific K-ras mutation in their tumors ID on day 7 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 and 12 weeks
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 18 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-G00-1775 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067783 | REGISTRY | None | None |