Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00005630


Primary Contact:

Study Chair
Lee M. Krug, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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