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

Memorial Sloan Kettering Cancer Center

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

ras peptide cancer vaccineBIOLOGICAL

sargramostimBIOLOGICAL

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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