Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00005630
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: July 1999
• Completion date: May 2002