Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
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.
Biological: ras peptide cancer vaccine
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial|
|Study Start Date:||July 1999|
|Study Completion Date:||May 2002|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005630
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Lee M. Krug, MD||Memorial Sloan Kettering Cancer Center.|