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Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer Clinical research trials and Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer  Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
For Condition: bronchoalveolar cell lung cancer,adenocarcinoma of the lung,stage 2 non-small cell lung cancer,stage 1 non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer,large cell lung cancer,stage 3A non-small cell lung cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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). II. Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 17 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 anti-inflammatory drugs --Patient Characteristics-- - Age: Over 17 - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeKrug, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067783; MSKCC-99028,NCI-G00-1775
Study Start Date: July 1999
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005630
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
2. Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
3. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
4. Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
5. Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
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