|
Vaccine Therapy 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 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 in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Vaccine Therapy 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 in Treating Patients With Non-Small Cell Lung Cancer. Vaccine Therapy 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 in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Vaccine Therapy 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.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer  Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 1 non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Suspended
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.
Details: OBJECTIVES: - Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer. - Determine the immunologic response in patients treated with this vaccine. OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer - Tumor diameter of at least 3 cm PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST less than 2 times upper limit of normal (ULN) - Lactate dehydrogenase less than 2 times ULN - Hepatitis B and C negative Renal: - Creatinine no greater than 1.4 mg/dL Other: - Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test) - HIV negative - No active systemic infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biological materials Chemotherapy: - At least 4 weeks since prior cytotoxic or chemotherapeutic agents - Concurrent chemotherapy allowed after surgery and before vaccination Endocrine therapy: - No concurrent steroid therapy Radiotherapy: - At least 4 weeks since prior radiotherapy - Concurrent radiotherapy allowed after surgery and before vaccination Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyAnderson, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000068881; NCI-G01-2007,RPCI-RP-9907
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023985
Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
2. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
3. Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer
4. Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
5. EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Related Studies:
Other stage 2 non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
