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Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical research trials and Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer. Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare available for their Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer  Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modifiedvirus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirusp53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of autologous dendritic cell-adenovirus p53 vaccine, administered after standard chemotherapy, in patients with extensive stage small cell lung cancer. - Determine the toxicity of this regimen in these patients. - Determine the development of an anti-p53-specific immune response in these patients after treatment with this regimen. - Determine the tumor response rate, time to progression, and overall survival of patients treated with this regimen. - Determine the frequency of anti-adenovirus immune responses in these patients after treatment with this regimen. OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus p53 vaccine. Patients undergo leukapheresis and dendritic cells are cultured. Adenovirus carrying p53 gene particles are added to the dendritic cells to make the vaccine. Leukapheresis is performed before chemotherapy or 8 weeks after the last dose of chemotherapy if the patient has already started chemotherapy. Patients receive standard chemotherapy before receiving the vaccine. The recommended regimen is carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with progressive disease (PD) at 6 weeks after chemotherapy are removed from the study. - Beginning 9 weeks after completion of chemotherapy, patients receive autologous dendritic cell-adenovirus p53 vaccine subcutaneously (SC) on days 1, 14, and 28. Patients without PD may undergo repeat leukapheresis on day 49. Patients receive vaccine SC again on days 56, 84, and 112 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of autologous dendritic cell-adenovirus p53 vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive autologous dendritic cell-adenovirus p53 vaccine at the MTD determined in phase I. Patients are followed at day 140 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 43-58 patients (3-18 for phase I and 40 for phase II) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed small cell lung cancer - Extensive stage disease - Measurable disease - No uncontrolled CNS metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hematocrit greater than 25% Hepatic - Bilirubin less than 2.0 mg/dL Renal - Creatinine less than 2.0 mg/dL Immunologic - HIV negative - No serious ongoing infection - No pre-existing immunodeficiency - No known pre-existing autoimmune disorder Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - At least 4 weeks since prior steroids (before vaccination) - No concurrent chronic steroids (during vaccination) Radiotherapy - At least 2 weeks since prior radiotherapy (before vaccination) Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottAntonia, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Scott Antonia 813-972-8400, ext. 2677
Additional Information:
Study ID Numbers: CDR0000257814; MCC-12614,MCC-0205538,MCC-13427,MCC-6260,MCC-IRB-0147/NE
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049218
Other Extensive Stage Small Cell Lung Cancer Studies:
1. CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Combination Chemotherapy With or Without Oblimersen in Treating Patients With Extensive-Stage Small Cell Lung Cancer
3. Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer
4. Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
Other Florida Clinical Trials
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Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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