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EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer Clinical research trials and EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer. EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer clinical trial. Subjects often receive the most expert healthcare possible for their EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer  EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
For Condition: stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Recruiting
Sponsor(s): Epimmune ,
Synopsis: RATIONALE: Vaccines such as EP-2101 made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of the EP-2101 vaccine in treating patients who have received standard therapy for stage IIB or stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: - Determine the safety and tolerability of EP-2101 peptide vaccine in patients with stage IIB or IIIA non-small cell lung cancer. - Determine the frequency of response in patients treated with this vaccine. - Determine the breadth of tumor-associated antigen-specific cytotoxic T-lymphocyte (CTL) response in patients treated with this vaccine. - Determine the magnitude of each epitope-specific CTL response in patients treated with this vaccine. - Determine the overall CTL response for each epitope in patients treated with this vaccine. OUTLINE: This is an open-label, multicenter study. Patients receive EP-2101 peptide vaccine emulsified in Montanide ISA-51 subcutaneously every 3 weeks for a total of 6 vaccinations in the absence of unacceptable toxicity. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer meeting 1 of the following staging criteria: - Stage IIB (T2, N1, M0 or T3, N0, M0) - Stage IIIA (T1, N2, M0; T2, N2, M0; T3, N1, M0; or T3, N2, M0) - No evidence of disease after prior standard treatment with curative intent - Therapy completed within the past 4 to 12 weeks - HLA-A2 positive PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin at least 10 g/dL - Platelet count greater than 100,000/mm^3 - WBC greater than 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Absolute lymphocyte count greater than 500/mm^3 Hepatic - AST and ALT no greater than 2.5 times upper limit of normal (ULN) - Bilirubin less than 3 mg/dL - Alkaline phosphatase no greater than 2.5 times ULN - No history of hepatitis B or C Renal - Creatinine no greater than 1.5 times ULN Immunologic - No prior serious adverse reactions, including anaphylaxis and related symptoms such as hives or respiratory difficulty, to any vaccines - No prior hypersensitivity to any components of the study vaccine - No history of any of the following conditions: - Systemic lupus erythematosus - Scleroderma - Connective tissue disease - Sjögren's syndrome - Rheumatoid arthritis - Inflammatory bowel disease - HIV negative Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 weeks after study treatment - No other prior cancer except successfully excised nonmelanomatous skin cancer or surgically cured carcinoma in situ of the cervix - No other acute medical condition that would preclude study therapy - No mental or psychiatric condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No prior vaccine therapy for cancer - More than 1 month since prior interferon therapy - More than 1 month since prior interleukin therapy - More than 1 month since prior influenza vaccine - More than 1 month since other prior immunomodulatory agents - No other concurrent immunomodulatory agents - No concurrent influenza vaccine Chemotherapy - Not specified Endocrine therapy - More than 1 month since prior systemic corticosteroids Radiotherapy - Not specified Surgery - Not specified Other - No concurrent participation in any other investigational study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottPlasman, Study Chair, Epimmune
University of Washington School of Medicine *Recruiting*
Seattle, Washington, 98195-6527
United States
Recruiting Mary (Nora) Disis 206-616-1823
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Michael Morse 919-684-5705
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-5907
United States
Recruiting Robert Figlin 310-794-6501
U.S. Oncology Research, Inc. *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Charles Cunningham 214-370-1780
Additional Information:
Study ID Numbers: CDR0000299053; USO-02081,EPIMMUNE-EP2101-101,UCLA-030106
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060047
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
2. Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
3. EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
4. Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
5. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
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