|
Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer health trials occur in hundreds of cities throughout the U.S.A.. 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 drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer. Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer  Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer,bronchoalveolar cell lung cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IIIB or stage IV bronchoalveolar (lung) cancer.
Details: OBJECTIVES: - Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine. - Determine the response rate (confirmed and unconfirmed and complete and partial) in patients treated with this vaccine. - Determine the frequency and severity of toxic effects of this vaccine in these patients. - Determine the functional status of patients treated with this vaccine. - Correlate systemic biologic activity (i.e., antigen-specific antitumor and systemic cytokine responses) with clinical outcome in patients treated with this vaccine. OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma (BAC) (yes vs no) and pattern of BAC (diffuse vs nodular). After successful vaccine manufacturing from tumor tissue procured, patients receive GVAX lung cancer vaccine intradermally (ID) (7-8 injections per vaccination) on weeks 1, 3, 5, 7, and 9 for a total of 5 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 9, 13, and 21. Patients are followed at 4 weeks, every 8 weeks for 1 year, and then every 12 weeks for 2 years. PROJECTED ACCRUAL: A total of 117 patients (67 previously untreated and 50 previously treated) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis* of 1 of the following by radiological features and clinical presentation: - Bronchoalveolar carcinoma (BAC) - Diffuse or ground glass appearance - Adenocarcinoma with bronchoalveolar features - BAC with focal invasion NOTE: *Histological confirmation (excluding fine needle aspiration or bronchial brushings or washings) is required after the tumor tissue has been procured and the vaccine has been produced - Selected stage IIIB (due to malignant pleural effusion) OR stage IV disease - Measurable or nonmeasurable disease (e.g., diffuse infiltrative process) by CT scan of the chest both before and after tumor tissue procurement for vaccine - Not a candidate for curative resection - Tumor accessible for tissue procurement via thoracentesis or a surgical procedure - If a pleural effusion is the source of tumor tissue, at least 600 mL of fluid must be available for vaccine manufacture - Resection of brain metastases may be used for vaccine processing - Surgery must be done after study entry - Asymptomatic previously treated (e.g., surgical resection or radiotherapy) brain metastases allowed provided the patient is neurologically stable - No active or impending spinal cord compression or evidence of pericardial tamponade PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - CD4 count greater than 200/mm^3 - No bleeding disorder Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) - SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases are present) Renal - Not specified Cardiovascular - See Disease Characteristics - No symptomatic congestive heart failure - No thrombolic disorder - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - No pulmonary hypertension - No significant baseline hypoxia (i.e., O_2 saturation less than 90% OR requires greater than 2 L/min of supplemental O_2 via nasal cannula) by an oxygen saturation test - No postobstructive pneumonia Immunologic - No active immune or autoimmune disease - No systemic lupus erythematosus - No sarcoiditis - No rheumatoid arthritis - No glomerulonephritis - No vasculitis - No serious infection - No hypersensitivity to any of the following: - Sargramostim (GM-CSF) - Pentastarch - Gentamicin - Human serum albumin - Dimethyl sulfoxide - Porcine trypsin - Fetal bovine serum - Recombinant benzonase - Other components of the vaccine or CG6444 adenoviral vector used in this study Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No poor nutritional status - No psychiatric illness or social situation that would preclude study compliance or increase operative risk - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - No prior gene therapy, including adenoviral-based therapy Chemotherapy - More than 4 weeks since prior chemotherapy - No prior regional chemotherapy administered through the pulmonary artery (if resection of the tumor in the treated lobe is planned) Endocrine therapy - More than 14 days since prior systemic corticosteroids - No concurrent steroids Radiotherapy - See Disease Characteistics - More than 4 weeks since prior radiotherapy - Disease must be outside the areas of prior radiotherapy OR clear progression at prior irradiated sites must be documented - No prior radiotherapy to the tumor mass targeted for resection Surgery - See Disease Characteristics - More than 7 days since prior surgery and recovered Other - No other concurrent nonprotocol-specified treatment - No concurrent immunosuppressants - No concurrent chronic anticoagulation therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRoberts, , University of California Davis Cancer Center
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Abdul-Rahman Jazieh 513-584-3830
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
Additional Information:
Study ID Numbers: CDR0000343797; SWOG-S0310
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074295
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
3. Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
4. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
5. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
|
|
|
|
|
|
|
|
