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Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , 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. Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of vaccine therapy with or without low-dose cyclophosphamide in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: Primary - Compare the clinical antitumor response in patients with stage IIIB or IV non-small cell lung cancer treated with CG8123 vaccine with vs without low-dose cyclophosphamide. Secondary - Compare improvement in quality of life, in terms of cancer-associated symptoms, of patients treated with these regimens. - Compare the immune responses induced by these regimens in these patients. - Compare the overall safety of these regimens, in terms of morbidity associated with surgical tumor harvest and drug toxicity, in these patients. - Compare the progression-free and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior chemotherapy for non-small cell lung cancer (yes vs no). Patients undergo either a surgical procedure (e.g., thoracoscopy, mediastinoscopy, or thoracotomy) or thoracentesis (for malignant pleural effusion) to obtain tumor cells for vaccine preparation. Patients for whom vaccine production is successful are randomized to 1 of 2 treatment arms. - Arm I: Patients receive CG8123 vaccine intradermally on day 0 of weeks 0, 2, 4, 6, and 8 for a total of up to 5 vaccinations. - Arm II: Patients receive CG8123 vaccine as in arm I and low-dose cyclophosphamide IV over 30 minutes on day -1 of weeks 0, 4, and 8. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at week 8 during study treatment, and then at 8 weeks after the completion of study treatment. Patients are followed at 4 and 8 weeks after the completion of study treatment, every 3 months for 2 years, and then annually for up to 15 years. PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) 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 (or suspicious diagnosis of) non-small cell lung cancer - Stage IIIB OR stage IV disease - Adequate tumor accessible for tissue procurement and vaccine production via thoracentesis or a surgical procedure - If a pleural effusion is the source of tumor tissue, 600 mL of pleural fluid must be obtained - Solid tumors are preferred to be 1 x 1 cm to ensure adequate mass for vaccine production - Histologically confirmed malignant cells in the tumor procured for vaccine processing - Successful vaccine production - Measurable disease remaining after tumor tissue procurement for vaccine - No active and/or untreated brain metastases - No active or impending spinal cord compression PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - CD4+ cell count > 200/mm^3 - WBC > 3,000/mm^3 - Absolute neutrophil count > 1,500/mm^3 - Hemoglobin > 9 g/dL - Platelet count > 100,000/mm^3 Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) - AST and ALT 2.5 times ULN (5 times ULN if liver metastases are present) - Albumin 2.5 mg/dL - INR < 1.3 - PTT < 45 seconds Renal - Creatinine 2.0 mg/dL - No uncontrolled genitourinary condition that would preclude study participation Cardiovascular - No congestive heart failure*, defined by either of the following: - LVEF < 40 % - Evidence of right heart failure - No uncontrolled cardiovascular condition that would preclude study participation - No impending cardiac tamponade by echocardiogram (in patients with pre-existing pericardial effusions) NOTE: *If a major surgical procedure is planned for tumor harvest (e.g., thoracoscopic, laparoscopic, thoracic, abdominal, or neurological surgery) requiring general anesthesia, not including resection of a peripheral soft tissue mass or thoracentesis for pleural effusion performed under local or regional anesthesia Pulmonary - Oxygen saturation 90% on 2 L of supplemental oxygen by nasal cannula - If resection of a lung mass by thoracoscopic surgery or thoracotomy is planned, the following criteria must be met: - PaCO_2 < 45 mm Hg by arterial blood gases - FEV - must meet one of the following criteria: - Preoperative FEV_1 50% of predicted or 2L - Predicted post-resection FEV_1 1.0 L - DLCO must meet one of the following criteria: - Pre-operative DLCO > 60% of predicted - Predicted post-resection DLCO > 40% of predicted - Able to walk 1,000 feet in 6 minutes (unless limited by musculoskeletal disability) - No pulmonary hypertension* (i.e., pulmonary artery systolic pressure > 40 mm Hg) - No uncontrolled pulmonary condition that would preclude study participation NOTE: *If a major surgical procedure is planned for tumor harvest (e.g., thoracoscopic, laparoscopic, thoracic, abdominal, or neurological surgery) requiring general anesthesia, not including resection of a peripheral soft tissue mass or thoracentesis for pleural effusion performed under local or regional anesthesia Immunologic - No known hypersensitivity to any of the following: - Sargramostin (GM-CSF) - Cyclophosphamide - Pentastarch - Human serum albumin - Dimethylsulfoxide - Porcine trypsin - Fetal bovine serum - Recombinant benzonase - Gentamicin - Other components of the vaccine used in this study or CG6444 adenoviral vector - No active autoimmune disease, including any of the following: - Systemic lupus erythematosus - Sarcoidosis - Rheumatoid arthritis - Glomerulonephritis - Vasculitis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 1 month after study participation - 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 that is currently in complete remission - No uncontrolled gastrointestinal condition that would preclude study participation - No uncontrolled neurologic condition that would preclude study participation - No other uncontrolled medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior gene therapy, including any adenoviral-based therapy - No other concurrent gene therapy - No other concurrent biologic therapy - No other concurrent immunotherapy - No other concurrent vaccines (e.g., influenza shot) on the day of or for the 7-day period after CG8123 vaccine administration Chemotherapy - At least 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) - No other concurrent chemotherapy Endocrine therapy - At least 2 weeks since prior immunosuppressive doses of systemic glucocorticoids - No concurrent hormonal therapy - No concurrent continuous immunosuppressive doses of systemic corticosteroids Radiotherapy - At least 2 weeks since prior radiotherapy - Up to 3 weeks of local radiotherapy (e.g., brain radiotherapy after resection of brain metastases) allowed as an intervening treatment between tumor procurement and initiation of study vaccine treatment - No prior radiotherapy to the tumor mass targeted for resection - No concurrent radiotherapy except local palliative radiotherapy approved by the study sponsor Surgery - See Disease Characteristics - Concurrent local palliative surgical procedure allowed provided it is approved by the study sponsor Other - More than 12 weeks since prior anticoagulation therapy - At least 2 weeks since other prior immunosuppressants - More than 4 weeks since prior participation in any other investigational trial - No intervening treatment with any approved or investigational cancer therapy from the time of tumor procurement to initiation of study vaccine treatment (except local radiotherapy explained above) - No concurrent participation in any other investigational trial - No concurrent continuous immunosuppressants - No other concurrent investigational therapy for the treatment of lung cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-5907
United States
Recruiting Robert Figlin 310-825-5788
Additional Information:
Study ID Numbers: CDR0000358798; CGI-D-0031,UCLA-0303040
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081016
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
2. Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
3. 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
4. Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
5. Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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