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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: ras peptide cancer vaccine
* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven stage IB-IV non-small cell lung cancer Non-squamous cell histology only Must have undergone curative surgery within the past 6 months and must be free of recurrence Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available PATIENT CHARACTERISTICS: Age: Over 17 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent medical condition that would preclude compliance or immunologic response to study treatment No other serious concurrent medical condition No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior postoperative chemotherapy and recovered Endocrine therapy: No concurrent systemic steroids Concurrent inhaled steroids allowed Radiotherapy: No prior radiotherapy to spleen At least 3 weeks since prior postoperative radiotherapy and recovered Surgery: See Disease Characteristics No prior splenectomy Other: No concurrent immunosuppressive drugs or antiinflammatory drugs

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ras peptide cancer vaccine|nan|
|Biological: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer